Author: Rachael Hansford

The first cell treatment for chronic motor deficit from TBI?

SB623 Demonstrated Sustained Improvement in Motor Impairment up to 48 Weeks and Associated with Improvement in Function and Activities of Daily Living in Patients with Chronic Traumatic Brain Injury

Positive results from the one-year analysis of the Phase 2 STEMTRA trial were presented for the first time at the 2022 American Academy of Neurology (#AAN2022) Annual Meeting, 4-7 April, 2022.

SB623 has the potential to be the first cell treatment for chronic motor deficit from TBI

The SanBio Group (SanBio Co., Ltd. of Tokyo, Japan, SanBio, Inc. of Mountain View, California, US, and SanBio Asia Pte. Ltd. of Singapore) announced on April 5 2022 that SB623 met the primary endpoint and demonstrated a trend toward maintaining the improvement of function and activities of daily living in the final, one-year analysis of the Phase 2 STEMTRA trial, which evaluated the efficacy and safety of SB623 compared to sham surgery in patients with chronic motor deficit from traumatic brain injury (TBI). These results were presented in an oral plenary session at the American Academy of Neurology (AAN) Annual Meeting on April 5, 2022, in Seattle, Washington, USA.

SB623 is an investigational, regenerative cell medicine comprised of bone-marrow-derived, mesenchymal stem cells that are implanted intracranially around the area of the injury.

“The results of this study are promising for the millions of people struggling with long-term disabilities caused by traumatic brain injury, many of whom are often overlooked in the healthcare system,” said Peter McAllister, M.D., board-certified Neurologist and Medical Director and Chief Medical Officer of the New England Center for Neurology and Headache.

These findings reinforce the potential for SB623 to provide clinically meaningful improvements in motor function and ability to resume daily activities.

Peter McAllister

In this clinical study involving a total of 61 patients, 46 were treated with SB623 and 15 underwent sham surgery as a control group. Patients treated with SB623 saw significant improvements in motor function at 24 weeks compared to sham surgery, as measured by the change from baseline in the Fugl-Meyer Motor Scale (FMMS), the study’s primary endpoint (8.3 [1.4] vs. 2.3 [2.5], p=0.04). These improvements in motor impairment were maintained up to 48 weeks in the treatment group. SB623 cell implantation was associated with an improvement of function and activities of daily living at 48 weeks, as measured by scales including Action Research Arm Test (ARAT), Gait Velocity and NeuroQOL upper and lower extremity function T scores.

SB623 was well tolerated, consistent with previous studies, and no new safety signals were identified. No patients withdrew due to adverse events, and there were no significant differences in the rate of adverse events between patients treated with SB623 and sham surgery.

In March 2022, SanBio completed approval filing based on the STEMTRA trial data with Japan’s Ministry of Health, Labour and Welfare (MHLW) for SB623 as a treatment for chronic motor deficit from TBI under the Sakigake Designation System. In addition to receiving the Sakigake designation, SB623 was granted orphan regenerative medicine designation by the MHLW and regenerative medicine advanced therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA).

“These data reaffirm the potential for SB623 to regenerate the brain after injury, an implication that would not only profoundly change the lives of those living with chronic traumatic brain injuries, but help shape the future of regenerative neurologic research,” said Keita Mori, chief executive officer at SanBio. “We have just completed the application for approval of SB623 in Japan based on these results, and will continue our efforts to obtain swift approval by responding promptly to the review by the regulatory authority, so that we can bring a new treatment option as quickly as possible to patients suffering from this underserved condition, which has no underlying cure.”

SanBio is preparing to initiate a Phase 3 trial for SB623 in the United States, where many traumatic brain injury patients currently live.

About Traumatic Brain Injury

Traumatic brain injury (TBI) is one of the leading causes of death and disability worldwide. The estimated global incidence of acute TBI during 2016 was 27 million cases, and the estimated global prevalence of chronic impairment secondary to TBI was 55.5 million cases.1 Overall, TBI and long-term motor deficits secondary to TBI significantly impair a person’s self-care, employability, and quality of life, and are major burdens on healthcare systems worldwide. In the United States, approximately 43% of surviving hospitalized persons with TBI experience long-term disabilities,2 and it is estimated that 3.17 million people are living with long-term disabilities secondary to TBI.3

About SanBio

SanBio is engaged in the regenerative cell medicine business, spanning research, development, manufacture, and sales of regenerative cell medicines. SanBio targets patients with high unmet medical needs that cannot be addressed by existing medical treatments, mainly in diseases of the central nervous system. SanBio is headquartered in Tokyo, Japan and has subsidiaries based in Mountain View, California, and Singapore. Additional information about SanBio Group is available at

About SB623

SB623 (INN: vandefitemcel) is a human (allogeneic) bone marrow-derived modified mesenchymal stem cell that is produced by modifying and culturing mesenchymal stem cells derived from the bone marrow aspirate of healthy adults. Implantation of SB623 cells into injured nerve tissues in the brain is expected to trigger the brain’s natural regenerative ability to restore lost functions. SB623 is currently being investigated for the treatment of several conditions including chronic neurological motor deficit resulting from traumatic brain injury and ischemic stroke.

About the STEMTRA Trial

STEMTRA is a 48-week, Phase 2, randomized, double-blind, surgical sham-controlled, global trial evaluating the efficacy and safety of SB623 compared to sham surgery in 61 patients with stable chronic motor deficits secondary to traumatic brain injury. In this study, SB623 was inserted via stereotactic, intracranial implantation. Patients underwent stratified randomization in a 1:1:1:1 ratio to receive either 2.5×106, 5×106 or 10×10SB623 cells or sham surgical procedure.

To be eligible for this trial, patients (ages 18-75) must have been at least 12 months post-TBI and had a Glasgow Outcome Scale extended (GOS-E) score of 3-6 (e.g., moderate or severe disability). Patients must also have been able to undergo all planned neurological assessments and had no seizures in prior three months. The primary endpoint was mean change from baseline in Fugl-Meyer Motor Scale (FMMS) score at six-months. The STEMTRA trial enrolled 61 patients from 13 surgical and 18 assessment sites globally, including the U.S. and Japan.


1James SL, et al. “Global, regional, and national burden of traumatic brain injury and spinal cord injury, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016.” Lancet Neurol 2019;18:56-87.

2Selassie AW, et al. “Incidence of long-term disability following traumatic brain injury hospitalization, U.S.”, 2003. J Head Trauma Rehabil 2008;23:123-31

3Zaloshnja E, Miller T, Langlois JA, Selassie AW. “Prevalence of long-term disability from traumatic brain injury in the civilian population of the United States, 2005.” J Head Trauma Rehabil. 2008 Nov-Dec;23(6):394-400.

Ublituximab trials in Multiple Sclerosis

 TG Therapeutics, Inc. announced data from the ULTIMATE I & II Phase 3 trials evaluating ublituximab in patients with relapsing forms of multiple sclerosis (RMS) at the American Academy of Neurology (#AAN2022) annual meeting, 2-7 April 2022 in Washington, USA. Highlights of the presentations are outlined below.

We are pleased to present additional analyses from the ULTIMATE I & II trials, which continue to highlight encouraging data for ublituximab as a potential treatment for patients with relapsing forms of multiple sclerosis. Of note, post hoc/pooled analyses demonstrate approximately 95% of ublituximab treated patients who demonstrated 12-week CDI sustained the improvement through the end of the study at week 96, a consistent NEDA benefit for ublituximab-treated patients was demonstrated across treatment epochs and key patient subpopulations, and 96% of patients completed their ublituximab infusions without interruptions. We believe these data reinforce the potential of ublituximab, if approved, to offer RMS patients a treatment option that can be administered in a one-hour infusion every six months after the first dose.

Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics

Poster Presentation Title: Disability Improvements With Ublituximab in Relapsing Multiple Sclerosis (RMS): Expanded Disability Status Scale (EDSS), 9-Hole Peg Test (9-HPT), and Timed 25-Foot Walk   (T25FW) Evaluations From the Phase 3 ULTIMATE I and II Studies

  • In pooled post hoc analyses of ULTIMATE I and II:
    • Among ublituximab patients who demonstrated 12-week Confirmed Disability Improvement (CDI), 95.4% (62/65) sustained the improvement through the end of the study at week 96.
    • In patients with a baseline Expanded Disability Status Score (EDSS) score ≥2.0, more patients in the ublituximab group than teriflunomide group had EDSS improvements of 1.0 and 1.5 points at Weeks 60, 72, 84, and 96 (P<0.05 for all)
    • At 96 weeks, a ≥20% improvement in 9-HPT was observed in 11.4% and 5.5% (dominant hand; P=0.0009) and 11.4% and 5.7% (nondominant hand; P=0.0016) of ublituximab (n=543) and teriflunomide (n=546) treated patients, respectively

Poster Presentation Title: Ublituximab Treatment Is Associated With a Significant Proportion of Patients Achieving No Evidence of Disease Activity (NEDA): Results From the Ultimate I and Ultimate II Phase 3 Studies of Ublituximab vs Teriflunomide in Relapsing Multiple Sclerosis (RMS)

  • ULTIMATE I and II post hoc pooled analyses demonstrated a consistent NEDA benefit for ublituximab treated patients across treatment epochs and key patient subpopulations
  • In pooled post hoc analyses evaluating NEDA-3 by treatment epoch and patient subtype:
    • NEDA-3 rates for ublituximab vs teriflunomide cohorts by treatment epoch at 0-96 weeks were 44.6% (232/520) vs 12.4% (65/524), respectively, and at 24-96 weeks (re-baselined) were 82.1% (418/509) vs 22.5% (115/511) (P<0.0001 for both)
    • NEDA-3 at 24-96 weeks (re-baselined) was achieved in 82.7% (268/324) vs 23.1% (81/350) of treatment-naive, 81.1% (34/161) vs 21.1% (150/185) of previously treated (prior disease-modifying therapy [DMT]), 82.4% (206/250) vs 18.6% (48/258) of early-disease, and 81.9% (212/259) vs 26.5% (67/253) of late-disease patients in ublituximab- vs teriflunomide-treated cohorts, respectively (P<0.0001 for all)
    • The leading cause of disease activity during Weeks 24-96 (re-baselined) was new/enlarging T2 lesions for teriflunomide (occurring in 71.6% of patients) and relapse for ublituximab (occurring in 11.4% of patients)

Poster Presentation Title: Infusion-Related Reactions (IRRs) With Ublituximab in Patients With Relapsing Multiple Sclerosis (RMS): Post Hoc Analyses From the Phase 3 ULTIMATE I and II Studies

  • In pooled analyses of the ULTIMATE studies, 96.6% of patients (n=545) completed ublituximab infusions without interruption, and 94.6% completed Dose 2-5 maintenance infusions within 1 hour±5 minutes
  • 43% of patients had an IRR at Dose 1, the proportion of patients experiencing an IRR markedly decreased to <10.0% for all subsequent infusions, and 69.5% did not have an IRR recurrence
  • 78.8% of Dose 1 and 69.2% of Dose 2 IRRs with ublituximab occurred during the infusion period or within 1 hour post infusion
  • The administration route of premedications (oral, intravenous [IV], intramuscular [IM], or mixed) did not impact the frequency of IRRs
  • IRRs were the prevailing adverse event (AE) with ublituximab in ULTIMATE I and II; the vast majority were mild to moderate in severity

The above presentations are available on the Publications page, located within the Pipeline section, of the Company’s website at

ULTIMATE I and ULTIMATE II are two independent Phase 3, randomised, double-blinded, active-controlled, global, multi-center studies evaluating the efficacy and safety/tolerability of ublituximab (450mg dose administered by one-hour intravenous infusion every 6 months, following a Day 1 infusion of 150mg over four hours and a Day 15 infusion of 450mg over one hour) versus teriflunomide (14mg oral tablets taken once daily) in subjects with relapsing forms of Multiple Sclerosis (RMS). The ULTIMATE I & II trials enrolled a total of 1,094 patients with RMS across 10 countries. These trials were led by Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University and were conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). As previously announced, both studies met their primary endpoint with ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate (ARR) compared to terifunomide over a 96-week period (p<0.005 in each trial). Additional information on these clinical trials can be found at (NCT03277261; NCT03277248).

Ublituximab is an investigational glycoengineered monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. When ublituximab binds to the B-cell it triggers a series of immunological reactions, including antibody-dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC), leading to destruction of the cell. Additionally, ublituximab is uniquely designed, to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, has been shown to enhance the potency of ublituximab, especially the ADCC activity. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of B-cell malignancies and autoimmune disorders, both diseases driven by the abnormal growth or function of B-cells.

TG Therapeutics is a fully-integrated, commercial stage biopharmaceutical company focused on the acquisition, development and commercialisation of novel treatments for B-cell malignancies and autoimmune diseases. In addition to an active research pipeline including five investigational medicines across these therapeutic areas, TG has received accelerated approval from the U.S. FDA for UKONIQ® (umbralisib), for the treatment of adult patients with relapsed/refractory marginal zone lymphoma who have received at least one prior anti-CD20-based regimen and relapsed/refractory follicular lymphoma who have received at least three prior lines of systemic therapies. Currently, the Company has three programmes in Phase 3 development for the treatment of patients with relapsing forms of multiple sclerosis (RMS) and patients with chronic lymphocytic leukemia (CLL) and several investigational medicines in Phase 1 clinical development. For more information, visit

UKONIQ® is a registered trademark of TG Therapeutics, Inc.

PIVOT-HD Phase 2 Clinical Trial in Huntington’s Disease

PTC Therapeutics, Inc. announced on 31st March 2022 the initiation of the PIVOT-HD Phase 2 clinical trial evaluating PTC518 in people with Huntington’s disease (HD). PIVOT-HD is a global trial starting in the United States. PTC518 is an oral, small molecule splicing modifier that was specifically designed to selectively lower huntingtin mRNA and protein. There are no current treatments for the underlying cause of HD.

“We are excited to advance our Huntington’s disease programme,” said Stuart W. Peltz, CEO, PTC Therapeutics.

In the PIVOT-HD trial, we aim to confirm the dose-dependent lowering of huntingtin protein that was demonstrated in our Phase 1 clinical study and gain insight to biomarker data that could provide meaningful evidence of treatment effect.

Stuart W. Peltz, CEO, PTC Therapeutics.

The PIVOT-HD Phase 2 clinical trial is designed in two parts: an initial 12-week placebo-controlled phase focused on PTC518 pharmacology and pharmacodynamic effect, followed by a 9-month placebo-controlled phase focused on PTC518 biomarker effect.

About Huntington’s Disease

Huntington’s disease (HD) is a rare, inherited disease that causes the progressive degeneration of nerve cells in the brain that has broad impact on a person’s motor and functional capabilities, resulting in both movement disorders and cognitive loss. While HD can present at any age, it is most prevalent in people aged 30 to 50, and it affects approximately 45,000 people in the United States. HD is caused by a mutation in the huntingtin gene, which is responsible for creating huntingtin protein (HTT). As time progresses, the mutated huntingtin protein forms clumps in the brain cells, resulting in damaged cells and eventually cell death. HD has broad impact on a person’s motor and functional capabilities that results in both movement disorders cognitive loss. There are no treatments for the underlying cause of HD.

About PTC518

PTC518 is a small molecule splicing modifier that acts via a unique mechanism to promote the inclusion of a novel pseudoexon containing a premature termination codon, thus triggering HTT mRNA degradation and subsequent reduction in HTT protein levels. In a Phase 1 healthy volunteer study of PTC518 for Huntington’s disease, PTC518 demonstrated a dose-dependent lowering of HTT mRNA and protein to the targeted 30-50% reduction. In addition, PTC518 showed that it passes the blood brain barrier and has minimal efflux which is a key factor in the targeting the underlying cause of Huntington’s disease.

Innovative IQoro neuromuscular treatment device achieves NHS prescription status

IQoro, a treatment device for swallowing dysfunction and acid-reflux based diseases, will be added to the Drug Tariff from May 1st this year. It has previously been used by around 75,000 individuals that have self-purchased, and by SLTs and neuro-rehab clinicians in 40 or more NHS trusts.

IQoro is a simple hand-held device that is used for 30 seconds per session, three times per day.

It is inserted pre-dentally and pulled forwards to create a low pressure in the oral cavity and stimulate all the 148 muscles involved in a normal swallow. The sensory cranial nerves in the mouth are stimulated to send intense afferent signals to the brain stem, thus invoking a sensory motor reflex arc that exercises and strengthens muscles beyond the command of voluntary system. The training effect promotes neuroplasticity in those patients with neurological conditions.

CTE Biobank launches in Australia

A national biobank to collect information and test samples relating to repeated traumatic brain injuries often associated with sport was launched on 22nd March 2022 in Australia, with New Zealand announcing its intention to establish a similar clinic and biobank.

Chronic traumatic encephalopathy (CTE) is a form of dementia that results from repeated head injuries, and is found in a cross-section of the community, from those engaged in contact and combat sports, to members of the military and survivors of domestic violence.

The symptoms include mood disturbance with depression and anxiety, behavioural disturbance with tendency of impulsivity and anger, changes in personality, impaired judgement and confusion with cognitive decline, and the effect on the people diagnosed and their families is devastating.

Currently there are no clinical tests to identify CTE; the disease can only be conclusively diagnosed by examining the brain after death.

The two biobanks will work together and seek to gather quality data and stored samples over the long term that can be reanalysed in future.

Macquarie University CTE researcher and Australian CTE Biobank (ACB) Director Dr Rowena Mobbs says patients and their families are desperate for more support from the community, and the clubs for whom they played.

“Make no mistake, CTE shatters lives – not only those of patients, but their families,” she says.

“Our aim is to develop specific biomarkers for CTE, detecting and treating it early – and ultimately preventing it.

“We hope that this could mean blood testing for CTE within five years, just as we see on the horizon for Alzheimer’s and other forms of dementia.

“If we are to prevent it, there needs to be major national reform and greater cohesion across policy, clinical practice, and occupational health and safety for professional athletes at risk of repetitive brain injury and CTE.

“New patients are presenting with CTE every week, highlighting just how important this research is for athletes and the sports they represent.

“We are inviting support for the research programme from the NRL, AFL, and Rugby Australia, all of whose players have been demonstrated to have CTE in Australia. CTE can be compared to other occupational diseases.”

Professor Maurice Curtis is head of the Centre for Brain Research at the University of Auckland, CoDirector of the CBR Neurological Foundation Human Brain Bank, and one of NZ’s leading neuroscientists in the field of neurodegenerative research.

“Momentum has been building towards the formation of the NZ CTE Research Clinic Biobank alongside other researchers on both sides of the Tasman,” he says.

“The work done here in New Zealand will complement that of our Australian colleagues and other leading groups around the world in this critical area of brain research.

The Australian CTE Biobank held its launch at Macquarie University on Tuesday, 22 March, with the assistance of Biobank Ambassadors including former NRL player James McManus and his wife Eshia McManus, former rugby union player Michael and his wife Francis Lipman, and former boxer Jeff Fenech.


Call For Evidence Consultation Launched For ABI Strategy

A Call for Evidence has been launched for the recently agreed cross departmental Government strategy for Acquired Brain Injury (ABI).

The UK Acquired Brain Injury Forum (UKABIF) joined other brain injury charities and organisations and people with acquired brain injury at the House of Commons this week where the Minister of State for Care and Mental Health, Gillian Keegan and Chris Bryant MP announced the launch of the Call for Evidence.

Chris Bryant, Chair of the All-Party Parliamentary Group on Acquired Brain Injury, secured the ABI strategy at the end of 2021 and he and Gillian Keegan co-chair the ABI strategy programme board which first met earlier this year.

Chloe Hayward, Executive Director of UK Acquired Brain Injury Forum (UKABIF), said: “We are very pleased the government is giving acquired brain injury the attention it deserves with the ABI Strategy.

The call for evidence will help the panel to focus and prioritise their efforts, so we need people with lived experience of brain injury – whether, survivors, carers or professionals – to participate. This will ensure the panel has the best available information to develop their strategy.

Chloe Hayward

Minister of State for Care and Mental Health, Gillian Keegan, said: “It is absolutely essential people living with acquired brain injury get the best possible care and treatment and that we take steps to prevent these injuries wherever possible.

“Together the cross-government programme board and the call for evidence will allow us to deliver a strategy to address issues that matter most to those with acquired brain injuries and other neurological conditions.”

Chris Bryant MP said: “I’m delighted that the government is starting to pull together a cross government strategy on acquired brain injury.

“We need people to come forward with ideas and suggestions based on their experience of brain injury as practitioners, patients or family members so we can get this strategy right.

“I urge everyone to take part if they think they have an insight to offer.”

To complete the Call for Evidence survey go to

If you require further information, contact

WFNR Franz Gerstenbrand Award 2022

Brain Awareness Week – WFNR Franz Gerstenbrand Award 2022 now open for entries

As we mark Brain Awareness Week, I’m delighted to announce that the World Federation for Neurorehabilitation (WFNR) Franz Gerstenbrand Award 2022 is now open, and we particularly encourage entries from individuals under the age of 35 years who are clinicians, researchers or allied health professionals currently working in neurorehabilitation.       

Professor David Good, WFNR President

The Award, worth £3,000, is open to WFNR members and non-members and recognises and rewards a neurorehabilitation project that has benefitted patients.  It is named after Professor Franz Gerstenbrand in recognition of his contribution to neurorehabilitation.

Entries for the WFNR Award must demonstrate a difference to patient outcomes and can involve any aspect of neurorehabilitation, such as a patient or clinic management initiative, research project, best practice development or the use of a new technological development.   The work described must be completed and produced results or been published in the last 12 months.

The Award is for a travel bursary to a clinical/scientific conference, professional development course or research project.  The deadline for the Award is the 31st October 2022.

Further information and an application form.

Music Therapy strikes a chord with traumatised emergency workers ​

The Blue Light Symphony Orchestra (BLSO), in collaboration with Chroma, successfully completed a pilot project delivering group Music Therapy to emergency service workers to help them recover from traumatic experiences.

Working with Surrey and Sussex Police, Surrey and East Sussex Fire and Rescue and Southeast Coast Ambulance Service, the project, a UK first, delivered a bespoke music therapy program for emergency workers. It drew inspiration from the USA where music therapy is widely used to treat PTSD and trauma-related issues is in army veterans.

The BLSO was awarded £10,000 funding from the Coronavirus Community Support Fund, distributed by The National Lottery Community Fund, recognising that Emergency Workers have been exposed to increased levels of trauma while responding to the Covid-19 pandemic.

Over 12 weeks, using a combination of psychodynamic music therapy, neurologic music therapy and dialectical behaviour techniques, emergency service personnel were able to experience, reflect, learn, and then transfer coping strategies into everyday life.

The group incorporated free improvisation, the learning of simple drumming techniques, blended with health and wellness education and interactive improvised music-making. Throughout the programme, the sense of camaraderie increased, alongside the enjoyment and playfulness that developed.

Seb Valentine, founder of the BLSO and serving Detective Sergeant with Surrey Police said: “We are extremely happy with the success of this project, bringing music therapy to emergency workers who develop mental health issues relating to the trauma they experience daily.

“Positive feedback from participants has meant we are planning to run another project in the Surrey Sussex area. I hope that when my colleagues see how successful this pilot was, it will reduce scepticism and encourage more to take advantage and benefit from the healing power of music.  

I would love to hear from any other emergency services organisations in England or Wales that would like to host a Music Therapy project. We are actively seeking funding opportunities and know that music therapy can help support the mental wellbeing of emergency service workers, so please do get in touch.

Seb Valentine, founder of the BLSO and serving Detective Sergeant with Surrey Police

Chroma will also be expanding the support, with the West Midlands Ambulance Service starting a similar project in May 2022.

Daniel Thomas, managing director at Chroma, added: “This was a wonderful project to be a part of. By the end of the 12 weeks, 71% of the participants’ recorded reduced levels of distress compared to their CORE-OM scores when they signed up for the program. “As a result of this success, we are pleased to be able to expand the project to offer more emergency service personnel vital support to support their physical, emotional and mental wellbeing.”

Click here for further information and a documentary video:
For more information regarding hosting a music therapy project, contact: Seb Valentine on 0777 337 2575 or via email

Copaxone® for use in breastfeeding mothers with RMS

  • Change to COPAXONE® (Glatiramer Acetate (GA)) Summary of Product Characteristics (SmPC) in breastfeeding is relevant for the Multiple Sclerosis (“MS”) community and provides information for neurologists and patients of the positive benefit/risk balance of use in breastfeeding
  • Relapsing Multiple Sclerosis (RMS) is 2-3 times more likely to affect womeni, with diagnosis most common during childbearing years
  • The SmPC update follows the recent COBRA Real World Evidence study of infants breastfed by mothers with MS undergoing GA treatment

Teva Pharmaceuticals Europe BV confirmed on 10th February 2022 that the SmPC for COPAXONE® (Glatiramer Acetate (GA) injection) 20mg/mL and 40mg/mL, indicated for the treatment of relapsing forms of multiple sclerosis (RMS) in Europe, has been updated. The product is now approved by EU health authorities for use in breastfeeding. The label update follows the review of clinical and non-clinical evidence, including latest data from the COBRA real world evidence study that investigated safety outcomes in infants breastfed by mothers with MS undergoing GA treatment during the first 18 months of life.ii

COBRA, the largest standardised analysis of data from the National German Multiple Sclerosis and Pregnancy Registry, assessed safety outcomes in a total of 120 infants including 60 of them breastfed by mothers under GA. It concluded that no evidence was found to suggest that infants were adversely affected by maternal exposure to GA during breastfeeding. This was measured by number of hospitalisations, antibiotic treatments, developmental delays and growth parameters in the first 18 months of life.iii The label update provides information for neurologists and other healthcare professionals treating MS patients of GA’s positive benefit/risk balance in breastfeeding.

Professor Kerstin Hellwig, Principal Investigator of COBRA RWE Study, Department of Neurology, Katholisches Klinikum Bochum, Germany says: “The benefits of breastfeeding for both mothers and their offspring are clinically meaningful and well-documented, but historically there has been limited clinical safety data for infants breastfed by mothers undergoing MS treatment. It is now believed breastfeeding could be protective for mothers with MS. The COBRA study results support mothers with MS in their choice to breastfeed without having to preclude MS treatment. This is an important contribution to current significant medical need.”

There are almost half a million women in Europe living with MS1; it is most common during childbearing age and about half of mothers with MS start their families after diagnosis. The pregnancy rate in MS is constantly increasingiv and recent research shows pregnancy does not worsen the disease progression (which traditionally has been a concern for patients).v

However, studies have found an increase in relapse incidence after child birth, in the postpartum periodvi, so MS treatment may need to be resumed. The majority of MS therapies’ labels advise against breastfeeding, so mothers are often faced with a choice to breastfeed their babies or restart their treatment. Given that according to a U.S. study approximately half of women with MS want to breastfeed vii, the safety of medications used to treat MS while breastfeeding is of concern to mothers. A further treatment option that can be used during breastfeeding may help address a significant medical need for mothers with MS.

Danilo Lembo M.D. VP Medical Europe, Teva Pharmaceuticals comments: “Our mission at Teva is to improve the lives of patients. This includes addressing gender inequalities in healthcare and understanding the unique challenges that women face during pregnancy and breastfeeding. The COPAXONE® label change provides breastfeeding patients with MS the choice to breastfeed while on MS treatment.”


i Pugliatti M et al. The epidemiology of multiple sclerosis in Europe. Eur J Neurol 2006;13(7):700-22.

ii Ciplea A, Kurzeja A, Thiel S, Haben S, Alexander J, Adamus E, Hellwig K. Safety analysis of offspring breastfed by mothers on glatiramer acetate therapy for relapsing multiple sclerosis. Eur.J.Neurol. 2021; 28(SUPPL 1): 201-202. 10.1111/ene.14973

iii Teva Pharmaceutical Industries Limited, 2021. New Safety Data on treatment with COPAXONE® (glatiramer acetate) of Breastfeeding Mothers who Live with Relapsing Multiple Sclerosis: COBRA study presented at the 7th Congress of the European Academy of Neurology (EAN). [online] Available at: [Accessed 1 February 2022].

iv Maria K. Houtchens, MD, Natalie C. Edwards, MSc, Gary Schneider, ScD, Kevin Stern, BA and Amy L. Phillips, Pregnancy rates and outcomes in women with and without MS in the United States, Neurology® 2018;91:e1559-e1569. doi:10.1212/WNL.0000000000006384

v Langer-Gould AM, Multiple Sclerosis & other CNS Inflammatory Diseases p. 773-792 June 2019, Vol.25,No.3,doi: 10.1212/CON.0000000000000745

vi Manson J. European Women With Multiple Sclerosis Feel Unprepared and Uneducated About Family Planning and Their Ability to Have Children – How Do We Improve Patient Education? European Neurological Review. 2018;13(1):21–4 DOI:

vii Lorifice L, et al. Neurol Ther 2021; doi: 10.1007/s40120-021-00297-6. Online ahead of print.