Theranica’s REN Wearable Becomes the First Ever Non-Pharmacological Migraine Treatment to Receive Commercial Coverage in the USA
Feb. 20, 2024: Theranica, a prescribed digital therapeutics company specialising in neuromodulation devices for migraine and other idiopathic pain conditions, announced the inclusion of its Nerivio Remote Electrical Neuromodulation (REN) wearable, for use in the acute and preventive treatment of migraine, under a commercial coverage policy of Highmark Inc (Highmark). This follows the successful completion of its Coverage with Evidence Development (CED) programme with Nerivio, launched in November 2022. The new commercial coverage policy marks a significant advancement in the accessibility of an effective, non-disruptive, and non-pharmacological migraine treatment.
Professor Christopher Gottschalk, MD, FAHS, Neurology Division Chief and Director of the Headache & Facial Pain Center at Yale University and the President of the Alliance for Headache Disorders Advocacy (AHDA), welcomed this coverage policy: “Americans with chronic conditions like migraine have faced a longstanding need for insurance coverage of neuromodulation devices and other non-pharmacological treatments. Nerivio is an evidence-based treatment that is supported by well-controlled trials, and this coverage policy is an encouraging milestone. We at the AHDA have high hopes that other US commercial insurers and Federally funded insurance plans will follow the very sensible footsteps of Highmark and recognise the importance of providing the 40 million Americans living with migraine with affordable access to drug-free prescription migraine treatments with clinical benefits properly backed by high-quality data.”
Highmark’s coverage decision for the Nerivio REN wearable follows a rigorous CED study with the device, assessing its clinical benefits over 384 members living with migraine. In the primary endpoint of the study, Nerivio demonstrated statistically significant results in the reduction in Migraine Disability Assessment Score (MIDAS) from 64.0 to 43.9 points (p<0.005). Additional clinically meaningful benefits were demonstrated with 75.8% of the participants experiencing pain relief within 2 hours post-treatment, 37.3% reporting pain freedom, 69.0% indicating functional disability relief, and 52.4% specifying full return to functional ability post 2 hours.
The CED study shows statistically significant and clinically meaningful benefits to migraine patients treated with the REN wearable in a real-world environment. This data highlights the importance of including REN among migraine therapies covered by insurance to address the unmet need for effective, safe, easy-to-use migraine intervention.”
Andrea Synowiec, DO, FAAN, Vice Chair of the Department of Neurology at Allegheny Health Network in Pennsylvania, Primary Investigator
Study led by Benedict Michael finds global cognitive deficits
A recent study on Preprint server Research Square suggests that brain fog, memory and concentration problems may be due to brain injury caused by the COVID-19 virus.
The study found that 351 patients hospitalised with severe COVID-19 had evidence of a long-term brain injury a year after contracting the SARS-CoV-2 virus – this was compared against 2,927 healthy controls. These findings were based on cognitive tests, self-reported symptoms, brain scans, and biomarkers.
More than 60% of COVID-19 survivors display persistent symptoms even months or years following recovery from the primary infection, significantly impacting their quality of life.
Treatment with corticosteroids during the acute phase appeared protective against cognitive deficits. The study authors suggest that “These findings support the hypothesis that brain injury in moderate to severe COVID-19 is immune-mediated, and should guide the development of therapeutic strategies.”
Drugs already licensed could be trialled to potentially treat secondary brain cancer, new research finds
The largest review of papers for brain cancer that has spread from the lungs has found abnormalities in the brain cancer. Licensed drugs could be clinically trialled to find out if they could treat the disease. The research led by the University of Bristol and published in Neuro-Oncology Advances also found genetic differences between smokers and non-smokers.
Around 25,000 patients in the UK suffer from cancer that has spread to the brain – known as metastases – most commonly from lung and breast cancer, and which causes death in the majority of these patients.
The genetic mutations in primary lung cancers have been widely studied, but less is known about the changes in the cancer once it has spread to the brain. The research team wanted to find out the genetic changes in brain metastasis from non-small cell lung cancer (NSCLC) and whether there are drugs already available that could potentially be offered to these patients.
The researchers carried out a review from 72 papers of genetic mutations in brain metastasis of NSCLC from 2,346 patients’ data on patient demographics, smoking status, genomic data, matched primary NSCLC, and PD-L1, which is a protein found on cancer cells.
The study found the most commonly mutated genes were EGFR, TP53, KRAS, CDKN2A, and STK11. Common missense mutations —mutations that lead to a single amino acid change in the protein coded by the gene— included EGFR L858R and KRAS G12C
In certain cases the genetic mutations were different in the brain metastasis from the primary lung cancer. There were also differences in the genetic mutations in smokers versus patients who had never smoked. Brain metastases of smokers versus non-smokers had different missense mutations in some mutated genes.
The research team found from the top ten commonly mutated genes which had primary NSCLC data, 37% of the specific mutations assessed were different between primary NSCLC and brain metastases. The researchers suggest Medicines and Healthcare products Regulatory Agency-approved drugs already licensed could potentially be tested to treat the disease in clinical trials.
Kathreena Kurian, Professor of Neuropathology and Honorary Consultant at North Bristol NHS Trust, Head of the Brain Tumour Research Centre at the University of Bristol and co-author of the paper, said: “Our research recommends that all patients should have their brain metastasis examined for mutations in addition to their primary lung cancer because they may be different.
“This evidence could form the backbone for new clinical trials for patients with brain metastasis in non-small cell lung cancer using drugs that are already available.”
Our research recommends that all patients should have their brain metastasis examined for mutations in addition to their primary lung cancer because they may be different. This evidence could form the backbone for new clinical trials for patients with brain metastasis in non-small cell lung cancer using drugs that are already available.
There has been a long-held belief that acute viral infections are directly responsible for neurological damage, but researchers from McMaster University have now discovered that it is the immune system’s response that is behind it.
The research, published on February 5, 2024 in Nature Communications, was led by Elizabeth Balint, a PhD student at McMaster, and Ali Ashkar, a Professor with the Department of Medicine and the Canada Research Chair in Natural Immunity and NK Cell Function.
“We were interested in trying to understand why so many viral infections are associated with neurological diseases,” says Balint. “Our evidence suggests that it’s not the virus itself that causes the damage, but a unique population of T cells, which are part of the immune system, that are actually responsible for the damage.”
Our evidence suggests that it’s not the virus itself that causes the damage, but a unique population of T cells, which are part of the immune system, that are actually responsible for the damage.
Elizabeth Balint, a PhD student at McMaster University
To come to this conclusion, the McMaster team focused on Zika virus. During laboratory testing, researchers, as expected, found T cells that were specific for Zika and designed to eliminate infected cells. They found something else, too.
“What was interesting in our study is that although we did find some T cells specific for Zika, we identified cells that weren’t functioning like a normal T cell and were killing lots of cells that weren’t infected with Zika.”
These cells are called NKG2D+CD8+ T cells and researchers say their aggressive response is responsible for neurological damage suffered from infections beyond just Zika, like COVID-19 and even septic shock.
The aggressive response is the result of the body producing large amounts of inflammatory proteins called cytokines, which in moderation help to coordinate the body’s response in battling an infection or injury by telling immune cells where to go and what to do when they arrive.
“If our body’s immune cells overreact and over produce inflammatory cytokines, this condition will lead to non-specific activation of our immune cells which in turn leads to collateral damage. This can have severe consequences if it happens in the brain,” Ashkar says.
The discovery offers researchers and scientists a new target for treatments of neurological diseases sparked by acute viral infections. In fact, Balint has already found a treatment that holds promise.
“Elizabeth has experimented with an antibody that can completely block and treat devastating neurotoxicity in the animal model, which is already in clinical trials for different uses in humans,” says Ashkar.
Balint hopes to continue her work towards finding a treatment that would be effective in humans.
“There are a few different other viruses we’re interested in studying, which will aid us in creating the best treatment options,” Balint says.
Funding for this study was provided by the Canadian Institutes of Health Research. Balint is also a recipient of a Canada Graduate Scholarship Doctoral Award.
31 January 2024; Biogen has announced that it will discontinue the development and commercialisation of ADUHELM® (aducanumab-avwa) 100 mg/mL injection for intravenous use and will terminate the ENVISION clinical study. This decision is not related to any safety or efficacy concerns. A large portion of the resources released resulting from termination of the ADUHELM programme will be redeployed in Biogen’s AD franchise.
We plan to further advance the launch of LEQEMBI, together with Eisai, and continue to bolster innovation with the development of the other assets in our pipeline. When searching for new medicines, one breakthrough can be the foundation that triggers future medicines to be developed. ADUHELM was that groundbreaking discovery that paved the way for a new class of drugs and reinvigorated investments in the field.”
Christopher A. Viehbacher, President and Chief Executive Officer of Biogen
In January 2023, Biogen began a strategic review of its research and development efforts, including seeking potential partners or external financing for ADUHELM, as part of a focus on prioritising the company’s portfolio. During this process, Biogen considered the time and investment required for the post-marketing confirmatory ENVISION study and the likely advancements in the field by the time of potential ADUHELM FDA traditional approval. Despite an extensive process, the company did not identify potential strategic partners or external financing.
“We have gained significant insight from the development of ADUHELM and will carry this forward as we continue our pioneering work in Alzheimer’s disease,” said Priya Singhal, M.D., M.P.H., Head of Development at Biogen. “We’d like to sincerely thank the trial investigators, healthcare providers, advocates, patients and families involved in the development of ADUHELM. We are grateful to Neurimmune for its scientific contributions and collaboration over many years.”
ADUHELM received accelerated approval from the U.S. Food and Drug Administration in June 2021. The Phase 4 post-marketing confirmatory ENVISION study was a requirement of FDA accelerated approval of ADUHELM.
Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both Eisai and Biogen commercialising and co-promoting the product and Eisai having final decision-making authority.
Orodispersible film formulation of disease-modifying drug riluzole now available to ALS patients in the UK
Emylif offers an alternative for the 80% of patients who experience difficulty swallowing during the course of their disease1
January 24, 2024: In November 2023, Zambon UK launched Emylif, a new formulation of riluzole in an orodispersible film – for the treatment of adults with amyotrophic lateral sclerosis (ALS). Emylif offers an alternative to the tablet administration of riluzole which can be difficult for patients to take as their disease progresses and they develop dysphagia (difficulty swallowing). Dysphagia occurs in around 80% of ALS patients over the course of their disease1.
Emylif is applied to the tongue and allowed to dissolve, with no need for water, tongue mobility or muscular strength. Studies have demonstrated that this mode of administration is bioequivalent to the tablet form of riluzole.2
Riluzole is the only disease-modifying treatment available to ALS patients in the UK. Currently, it is common practice for carers to crush riluzole tablets in order to administer them to patients who are finding it difficult to swallow tablets.3 Emylif offers a licenced alternative for these patients.
The safety profile of Emylif is very similar to that of other riluzole formulations, with the exception of oral hypoesthesia (numbness in the mouth). It is common for patients to experience mild and transient oral hypoesthesia which can last for an average of around 40 minutes.5 In a small-scale study in ALS patients there was no detrimental effect on swallowing following a single dose of riluzole orodispersible film.6 It is suggested that patients are counselled on the risk of numbness in the mouth so that they are not surprised or concerned if this occurs.
References
Muscaritoli M, Kushta I, Molfino A, Inghilleri M, Sabatelli M, Rossi Fanelli F. Nutritional and metabolic support in patients with amyotrophic lateral sclerosis. Nutrition (2012) 28(10):959-66. doi:10.1016/j.nut.2012.01.011
Di Stefano AFD, Radicioni MM, Segantin A, Gentili A, Baroglio C, Marjanović I, Cattaneo C (2022) Randomised, 2-Sequence, 4-Period Replicate Cross-Over Bioequivalence Study of a New Riluzole Orodispersible Film Vs. A Reference Tablet in Healthy Volunteers. J Bioeq Stud 8(1): 101
Dyer AM, Smith A. Riluzole 5 mg/mL oral suspension: for optimized drug delivery in amyotrophic lateral sclerosis. Drug Des Devel Ther. 2017;11:59-64. https://doi.org/10.2147/DDDT.S123776
Thong MY, Manrique YJ, Steadman KJ. Drug loss while crushing tablets: Comparison of 24 tablet crushing devices. PLoS One. 2018 Mar 1;13(3):e0193683. doi:10.1371/journal.pone.0193683. PMID:29494695; PMCID: PMC5832315
Emylif Summary of Product Characteristics
Wymer J, Apple S, Harrison A, Hill BA. Pharmacokinetics, Bioavailability, and Swallowing Safety With Riluzole Oral Film. Clin Pharmacol Drug Dev 2023 Jan;12(1):57-64.doi:10.1002/cpdd.1168
AboLiSh study demonstrates clinical benefit of injection guidance when treating spasticity with abobotulinumtoxinA
AboLiSh is the first global study to demonstrate the clinical benefit of using injection guidance techniques to improve patient goal attainment
Analyses of study data indicated that patients who are administered treatment with Dysport® (abobotulinumtoxinA) with the use of injection guidance techniques are nearly 3 times more likely overall to achieve their goals
The study highlights that almost 1 in 4 clinicians are not using injection guidance when administering abobotulinumtoxinA
19th January, 2024: Ipsen has announced top line results from its real-world AboLiSh study (NCT04050527), presented at the 7th international TOXINS conference in Berlin, Germany. The study evaluated utilisation and effectiveness of Dysport® (abobotulinumtoxinA) in people living with lower-limb spasticity and found that injection guidance techniques significantly help to improve outcomes and goal attainment in patients.
AboLiSh was a prospective 16-month observational study with a primary endpoint of goal attainment measured by subject centred Goal Attainment Scaling-Leg (LegA) T score. Topline results demonstrated statistically significant improvement in rehabilitation goal attainment in instances where physicians used guidance techniques, such as ultrasound, electrostimulation, electromyography or a combination of techniques, to deliver the first cycle of treatment to patients, compared to those receiving treatment without the use of guidance techniques. Patients who received abobotulinumtoxinA (AboBoNT) injections with the support of injection guidance were nearly 3 times (2.7) more likely overall to achieve their rehabilitation goals.
The AboLiSh study, which assessed 430 patients in 9 countries in Europe, the Americas, Australia and Russia, found that while the majority of clinicians already use guidance techniques, almost 1 in 4 clinicians (23%) administered AboBoNT without guidance, which was associated with reduced goal attainment and could lead to negative consequences, including patient adherence to neurotoxin injections.
“These findings highlight a current lack of consistency in how treatment is being administered to patients and underpin the importance of real-world evidence to inform clinical practice”, said Dr Alberto Esquenazi MD, Director Gait & Motion Analysis Laboratory at Jefferson Moss-Magee Rehabilitation in Philadelphia. “It is crucial that we consistently and routinely use our clinical assessment skills and the injection guidance tools available to us to ensure patients achieve their goals and their treatment is optimised.”
Patients who received abobotulinumtoxinA (AboBoNT) injections with the support of injection guidance were nearly 3 times (2.7) more likely overall to achieve their rehabilitation goals.
Ipsen is committed to further improving patient care for people living with spasticity and the study findings will be used to support Ipsen’s ongoing work to support the training of clinicians on the use of neurotoxin injections for the treatment of spasticity.
“We want to do our part to ensure those receiving treatment with Dysport have access to the best standards of care and are given every opportunity to achieve their goals.” says Sandra Silvestri, Chief Medical Officer, Ipsen. “To help facilitate this we are greatly expanding our Ixcellence program for neurology and rehabilitation specialists in 2024 which will utilise our global network of expert trainers to provide advanced education and knowledge transfer across a broad range of techniques essential to improving outcomes in patients with post stroke spasticity, including anatomy, ultrasound and goal setting.”
Clinicians taking part in the study were not given a protocol for the use of guidance techniques allowing them to treat patients in accordance with their standard practice. Results were determined using a cumulated (mean) Goal Attainment Scaling-Leg (LegA) T score, measuring the difficulty in passive and active muscle function following therapeutic intervention, across treatment cycles for each individual patient. No new safety signals were identified during the trial.
FDA approves Takeda’s Immune Globulin Infusion, Hyqvia
16 January, 2024;
The U.S. Food and Drug Administration (FDA) has approved HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent the relapse of neuromuscular disability and impairment in adults. HYQVIA first received approval in the U.S. in 2014 for the treatment of primary immunodeficiency (PI) in adults, which has since been expanded to include children 2-16 years old.1
HYQVIA is the only FDA-approved combination of immunoglobulin (IG) and hyaluronidase, which makes it a facilitated subcutaneous immunoglobulin (SCIG) infusion. For adults with CIDP, HYQVIA can be infused up to once monthly (every two, three or four weeks) due to the hyaluronidase component, which facilitates the dispersion and absorption of large IG volumes in the subcutaneous space between the skin and the muscle. Because it is delivered subcutaneously, HYQVIA can be administered by a healthcare professional in a medical office, infusion centre or at a patient’s home. In addition, it can be self-administered after appropriate patient or caregiver training.1
“With the FDA approval of HYQVIA for CIDP, which builds on our expertise in rare neuroimmunological and neuromuscular disorders, we can now offer a personalised maintenance treatment option for adults with this debilitating disease,” said Giles Platford, President of Takeda’s Plasma-Derived Therapies Business Unit. “Research and clinical experience have shown that IG therapy is effective as maintenance treatment in adults with CIDP, and we hope that this approval for HYQVIA is the first of several around the world as we strive to deliver our broad and diverse IG portfolio to more people with complex neuroimmunological diseases.”
This approval is based on results from a randomised, double-blinded, placebo-controlled study (ADVANCE-CIDP 1) and a single-arm, open-label, extension study (ADVANCE-CIDP 3) that evaluated the efficacy and safety of HYQVIA as a maintenance therapy in adults with CIDP. The efficacy evaluation included 122 adults from ADVANCE-CIDP 1 with a confirmed diagnosis of CIDP and who had remained on a stable dosing regimen of intravenous immunoglobulin (IVIG) therapy for at least three months prior to screening. The analysis of the primary endpoint demonstrated a statistically significant difference between the relapse rates in the HYQVIA group (N=57, 14.0%) compared to the placebo group (N=65, 32.3%) (p=0.0314). The treatment difference of -18.3% (two-sided 95% CI: -32.1%, -3.1%) indicated that HYQVIA demonstrated superiority over placebo in preventing relapse of CIDP.1
The safety of HYQVIA in adults with CIDP was evaluated across ADVANCE-CIDP 1 (N=62) and ADVANCE-CIDP 3 (N=79). The most common adverse reactions observed in >5% of study subjects in clinical studies of HYQVIA for CIDP were local reactions, headache, pyrexia, nausea, fatigue, erythema, pruritus, increased lipase, abdominal pain, back pain, and pain in extremity.1
We hope that this approval for HYQVIA is the first of several around the world as we strive to deliver our broad and diverse IG portfolio to more people with complex neuroimmunological diseases.
Giles Platford, President of Takeda’s Plasma-Derived Therapies Business Unit
CIDP is a rare, acquired, immune-mediated neuromuscular disorder affecting the peripheral nervous system.2,3 It is typically characterised by progressive, symmetric symptoms such as weakness, tingling or loss of feeling in distal and proximal limbs, loss of reflexes and difficulty walking.3 Because its symptoms may overlap with other rare, neuromuscular conditions, CIDP is often misdiagnosed.4 The mechanism of action of IG in the treatment of CIDP in adults has not been fully elucidated but may include immunomodulatory effects.1 The role of IG therapy as maintenance treatment in CIDP has been well-established and is the guidelines-based standard of care for this complex and heterogeneous condition.5 However, there are aspects of IVIG treatment that can be challenging for patients such as long treatment duration associated with high IG volumes, potential for venous access challenges, and infusion setting limitations.5
“While it is considered the standard-of-care for maintenance treatment of adults with CIDP, IVIG infusions may be challenging for some patients and their caregivers,” said Lisa Butler, executive director, GBS-CIDP Foundation International. “We’re excited that this therapy could offer some adults with CIDP an alternative subcutaneous option that may address some of these challenges and help personalise treatment.”
HYQVIA is now available as a maintenance therapy for adult patients with CIDP in the U.S.
In December 2023, Takeda announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of HYQVIA as maintenance therapy in patients with CIDP after stabilisation with IVIG. The European Commission (EC) will consider the CHMP positive opinion when determining the potential marketing authorisation for HYQVIA for CIDP throughout the European Union.6
References
HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] U.S. Prescribing Information.
GBS CIDP Foundation International. Voice of the Patient Report. August 26, 2022. http://www.gbs-cidp.org. Accessed August 2022.
UCB announces European Commission approval of RYSTIGGO®▼ (rozanolixizumab) for the treatment of adults with generalized myasthenia gravis in Europe
European approval of RYSTIGGO® (rozanolixizumab) granted as an add-on to standard therapy for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive1
Approval of this orphan medicinal product is based on pivotal Phase 3 MycarinG study in gMG,2 which demonstrated that treatment with rozanolixizumab resulted in statistically significant and clinically meaningful improvements in gMG-specific outcomes compared to placebo,2 including everyday activities such as breathing, talking, swallowing, and being able to rise from a chair3
Rozanolixizumab is the first therapy approved in Europe for adults with AChR or MuSK antibody-positive gMG, the two most common subtypes of gMG
The decision follows EC approval for UCB’s ZILBRYSQ®▼ (zilucoplan) in Europe for the treatment of adult patients with gMG, alongside U.S. FDA and Japanese MHLW approvals of rozanolixizumab and zilucoplan for the treatment of gMG in adult patients in 2023.4,5,6,7
UCB is the first and only company to offer a gMG-focused portfolio, that provides patients and clinicians the option of targeted therapies for both anti-AChR and anti-MuSK antibody-positive gMG
8th January 2024: UCB, a global biopharmaceutical company, today announced that the European Commission (EC) granted a marketing authorisation for RYSTIGGO® (rozanolixizumab) on 5th January 2024 as an add-on to standard therapy for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive1.
Rozanolixizumab 140 mg/ml solution for injection is a humanised IgG4 monoclonal antibody that binds to the neonatal Fc receptor (FcRn) resulting in the reduction of circulating IgG.2 It is the first therapy approved in Europe for adults with anti-AChR or anti-MuSK antibody-positive gMG, the two most common subtypes of gMG.
In December 2023, the EC also granted a marketing authorisation for UCB’s ZILBRYSQ®▼(zilucoplan) as an add-on to standard therapy for the treatment of gMG in adult patients who are anti-AChR antibody-positive4. Zilucoplan is a once-daily subcutaneously (SC) injected, self-administered peptide inhibitor of complement component 5 (C5 inhibitor).8
In progressing a portfolio of medicines for the treatment of gMG, with the aim of providing HCPs the option of addressing either complement activation or pathogenic antibodies for appropriate patients, UCB hopes to offer a comprehensive portfolio of targeted therapeutics, embodying a commitment to addressing the gMG community’s unmet needs.
With the EC approval of rozanolixizumab, alongside their recent approval of zilucoplan, I’m very excited that our gMG portfolio is now approved for use by healthcare professionals across Europe. This represents another important milestone in our ambition to deliver new and additional patient value to the gMG community and continues our launch trajectory. We believe there is still a significant unmet need within the gMG community which can be addressed by bringing differentiated, generally well-tolerated, and effective treatment options to patients that address key aspects of gMG pathophysiology.
Jean-Christophe Tellier, CEO, UCB
EC approval of rozanolixizumab is supported by safety and efficacy data from the pivotal Phase 3 MycarinG study (NCT03971422), published in The Lancet Neurology in May 2023.2
This announcement follows approvals of rozanolixizumab and zilucoplan by the Japanese Ministry of Health, Labour and Welfare (MHLW) for treatment of gMG in adult patients (only for patients who inadequately respond to steroids or other immunosuppressants), approval of rozanolixizumab by the U.S. Food and Drug Administration (FDA) for the treatment of gMG in adult patients who are anti-AChR or anti-MuSK antibody positive , and approval of zilucoplan by the FDA for the treatment of gMG in adult patients who are AChR antibody-positive. 7,5,6
Orphan designation was granted by the European Commission in 2020 to rozanolixizumab for the treatment of myasthenia gravis and maintained after having received the positive CHMP Opinion.9
The approval of rozanolixizumab from the EC is valid in all EU member states, as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein, and Norway.
UCB is committed to making rozanolixizumab available to patients as quickly as possible and anticipates European availability will commence in the first quarter of 2024.
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Bril V. Efficacy and safety of rozanolixizumab in patients with generalised myasthenia gravis: a randomised, double-blind, placebo-controlled, adaptive Phase 3 study MycarinG study. Lancet Neurol. 2023;22(5):383-94.
Wolfe Gl, et al. Myasthenia gravis activities of daily living profile. Neurology. 1992;52(7):1487-9.
Howard JF Jr, et al. Safety and efficacy of zilucoplan in patients with generalised myasthenia gravis (RAISE): a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Neurol. 2023;22(5):395-406.
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