Author: rachael_acnr

Fampridine recommended for use in England

Posted on July 23, 2026 by - Industry News, Multiple Sclerosis

NHS England has recommended fampridine for routine use in adults with multiple sclerosis (MS), improving access to the only licensed medicine shown to enhance walking ability in eligible patients. The decision, announced on 17 July 2026, follows years of campaigning and is expected to broaden access as generic versions become available after the expiry of the branded Fampyra patent at the end of July 2026.

The recommendation is expected to benefit adults with MS who have an Expanded Disability Status Scale (EDSS) score of 4 to 7 and meet prescribing criteria, including normal renal function and no history of seizures. Clinical evidence suggests that around 40% of people treated with fampridine experience a meaningful improvement in walking speed, with average gains of approximately 25% among those who respond.

The approval brings England into line with Wales, Scotland and Northern Ireland, where fampridine has already been adopted for routine use. Until now, access in England has been limited, leaving some people to fund treatment privately or go without despite availability elsewhere in the UK.

Patient organisations have welcomed the decision, describing it as an important milestone in improving equity of access for people living with MS. More than 120,000 people in England are affected by the condition, and improved access to mobility-enhancing treatment is expected to have a positive impact on independence and quality of life for eligible patients.

Although the recommendation has been made nationally, implementation is expected to take time while local NHS services establish prescribing and monitoring pathways. National organisations are working with integrated care systems and specialist services to support a consistent rollout across England.

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The approval represents a significant step towards reducing UK regional variation in access to MS treatments and ensuring eligible patients can receive the only licensed therapy currently available to improve walking ability.

This news item has been summarised using AI and checked by humans before publication.

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FDA approves at-home subcutaneous lecanemab initiation for early Alzheimer’s disease

Posted on July 15, 2026 by - Alzheimer's Disease, Dementia

The US Food and Drug Administration (FDA) has approved a supplemental biologics licence application for LEQEMBI IQLIK (lecanemab-irmb) as a once-weekly subcutaneous initiation treatment for adults with early Alzheimer’s disease. The decision makes LEQEMBI IQLIK the first anti-amyloid therapy approved for both initiation and maintenance dosing at home using an autoinjector in the United States.

LEQEMBI is indicated in the US for adults with mild cognitive impairment or mild dementia due to Alzheimer’s disease, with confirmed amyloid pathology before treatment. The newly approved initiation regimen consists of 500 mg once weekly, administered as two 250 mg subcutaneous injections, each delivered in approximately 15 seconds. Following 18 months of treatment, patients may continue with a 360 mg once-weekly maintenance dose administered subcutaneously or remain on intravenous therapy. Patients can also switch between intravenous and subcutaneous administration during treatment.

The approval is supported by a clinical data package that included sub-studies from the Phase 3 Clarity AD long-term extension trial. Weekly subcutaneous dosing achieved drug exposure comparable to intravenous infusion, supporting similar efficacy and amyloid plaque removal. The overall safety profile was generally consistent with intravenous administration, with exposure-related rates of amyloid-related imaging abnormalities with oedema (ARIA-E) expected to be comparable. Injection-site reactions occurred with subcutaneous dosing but were typically localised and mild.

Lecanemab carries a boxed warning for ARIA, including cerebral oedema and cerebral microhaemorrhages, which may be serious or, rarely, fatal. MRI monitoring before and during treatment remains recommended, and APOE ε4 homozygous patients are known to have an increased risk of ARIA. Appropriate patient selection and monitoring therefore remain essential when prescribing therapy.

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The companies say the availability of an at-home initiation option could reduce the burden of infusion appointments for patients and carers, decrease reliance on infusion services, shorten treatment administration times and preserve infusion capacity for patients who require or prefer intravenous therapy. In an autoinjector acceptability study, 94% of patients and care partners reported that the device was easy to use and expressed confidence administering treatment in the home setting.

LEQEMBI first received traditional FDA approval in 2023 after the Phase 3 Clarity AD trial demonstrated a 27% slowing of clinical decline over 18 months compared with placebo in patients with early Alzheimer’s disease. The latest approval expands the available route of administration rather than the approved patient population.

Eisai and Biogen plan to launch LEQEMBI IQLIK in the United States in late August 2026.

This news item has been summarised using AI and checked by humans before publication.

Sources

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First view of alpha-synuclein pathology in the living brain

Posted on July 14, 2026 by - Alzheimer's Disease, Movement Disorders, Parkinson’s Disease

Researchers have reported the first successful visualisation of pathological alpha-synuclein aggregates in the living human brain using a novel positron emission tomography (PET) tracer, a development that could transform the diagnosis and monitoring of Parkinson’s disease and related neurodegenerative disorders.

The study, published in Science Translational Medicine, describes the development and validation of [11C]MODAG-005, a PET tracer created by German biotechnology company MODAG in collaboration with University Hospital Tübingen and the Max Planck Institute for Multidisciplinary Sciences. The tracer selectively binds to pathological alpha-synuclein aggregates, allowing them to be detected using PET imaging.

Alpha-synuclein aggregation is a defining pathological feature of Parkinson’s disease, multiple system atrophy (MSA) and dementia with Lewy bodies. Until now, clinicians have lacked a reliable method for directly visualising these protein deposits in living patients, limiting opportunities for early diagnosis and disease-specific treatment.

The researchers validated the tracer through laboratory studies, animal models and first-in-human imaging in three patients. According to the study, [11C]MODAG-005 demonstrated high affinity and specificity for pathological alpha-synuclein aggregates while producing high-quality PET images. Early findings also suggest that distinct neurodegenerative disorders may exhibit characteristic patterns of tracer uptake, potentially enabling biology-based differential diagnosis.

The imaging agent complements MODAG’s existing PD DETECT® cerebrospinal fluid assay, which identifies pathological alpha-synuclein biochemically. Combining molecular testing with PET imaging could provide both confirmation of disease pathology and information on its anatomical distribution and progression.

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Beyond diagnosis, the tracer may prove valuable in therapeutic development. By enabling researchers to determine whether investigational drugs engage their intended target within the brain, it could provide an objective biomarker for evaluating disease-modifying therapies in clinical trials. MODAG highlighted its ongoing Phase 2 evaluation of emrusolmin for MSA, being conducted with Teva Pharmaceutical Industries, as one programme that could benefit from the technology.

The company is also developing a fluorine-18 labelled successor, [18F]MODAG-009, which is intended to improve tracer availability beyond specialist imaging centres and support wider clinical adoption.

This news item has been summarised using AI and checked by humans before publication.

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Sources

MODAG press release

Original publication: [11C]MODAG-005 – a PET tracer targeting alpha-synuclein aggregates in the brain. Science Translational Medicine, 2026. https://www.science.org/doi/10.1126/scitranslmed.aec0813

Choose Neurology

Posted on June 24, 2026 by - ACNR News, Industry News

People are often frightened of neurological conditions, and that goes for clinicians as well as patients! Neurophobia is well documented among medical students and non-neurologist doctors. Neurology is often perceived as complex and intimidating.

Project Neurology was launched with the goal of tackling Neurophobia among (primarily) students, trainees and early career doctors. However, what started as a teaching initiative has now developed even further.

Demand for treatment of neurological conditions is huge. Around 1 in 6 people in the UK live with a neurological condition. As demand continues to grow, so does the need for clinicians and researchers who are passionate about advancing knowledge and improving lives.

We need more specialists to choose neurology.

Jonny Acheson understands this better than most. An emergency medicine consultant diagnosed with Parkinson’s disease at the age of 41, he has experienced neurology from both sides of the consultation. As Jonny says, “Neurology stopped being a referral pathway. It became personal.”

He reminds us that alongside the science and cutting-edge research are human stories, and the chance to help people live well despite life-changing conditions.

Watch Jonny’s story below.

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Teva files FDA application for ecopipam in paediatric Tourette syndrome

Posted on June 23, 2026 by - Movement Disorders, Uncategorized

Teva Pharmaceutical Industries has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for ecopipam, an investigational treatment for paediatric Tourette syndrome. The company says the submission marks a significant milestone for what could become the first new FDA-approved therapy for children and adolescents with Tourette syndrome in more than a decade.

The application is supported by positive Phase 3 clinical trial results that were recently published in JAMA Neurology. In the study, ecopipam significantly delayed the time to relapse compared with placebo in paediatric patients who had previously responded to treatment during an open-label phase. The trial met its primary endpoint, demonstrating a statistically significant benefit for patients receiving ecopipam.

Ecopipam is a first-in-class selective dopamine D1 receptor antagonist. Unlike existing therapies that primarily target dopamine D2 receptors, the treatment has a novel mechanism of action designed to block dopamine signalling at the D1 receptor. Researchers believe D1 receptor hypersensitivity may contribute to the repetitive and compulsive behaviours associated with Tourette syndrome.

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According to Teva, the treatment was generally well tolerated in the Phase 3 study. The most commonly reported adverse events included somnolence, insomnia, anxiety, fatigue and headache. The therapy has already received both Orphan Drug and Fast Track designations from the FDA, highlighting its potential importance for a condition with limited treatment options.

Tourette syndrome is a chronic neurodevelopmental disorder characterised by involuntary motor and vocal tics that typically begin in childhood. Symptoms can be disruptive and may affect quality of life, while current treatments are often associated with limited efficacy or unwanted side effects. Teva argues that ecopipam could address an important unmet need if approved.

The NDA submission follows Teva’s acquisition of the ecopipam programme and forms part of the company’s broader strategy to expand its innovative medicines portfolio. The FDA will now review the application and determine whether the treatment can proceed towards approval in the United States.

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Sources

This news item has been summarised using AI and checked by humans before publication.

AbbVie’s AQUIPTA® (atogepant) is recommended by NICE as an option for the acute treatment of migraine in adults

Posted on June 10, 2026 by - Headache, Industry News

• The National Institute for Health and Care Excellence (NICE) has issued Final Draft Guidance (FDG) recommending AQUIPTA® (atogepant), an oral tablet, as an option for the acute treatment of migraine with or without aura in adults, only if, for previous migraines: at least two triptans were tried and they did not work well enough, or triptans were contraindicated or not tolerated, and nonsteroidal anti-inflammatory drugs (NSAIDs) and paracetamol were tried but did not work well enough.¹

• The NICE recommendation follows the granting of Marketing Authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) on April 22, 2026, for AQUIPTA® for the acute treatment of migraine with or without aura in adults.¹ Suitable acute migraine patients will soon have the option to be prescribed atogepant on the NHS in England and Wales.¹

• The recommendation is based on results from ECLIPSE, a pivotal Phase 3 study in which 24.3% of patients treated with atogepant achieved pain freedom at 2 hours post-dose following the first migraine attack, compared with 13.1% for placebo (p<0.0001).²

10 June 2026 — AbbVie today announced that the National Institute for Health and Care Excellence (NICE) has issued Final Draft Guidance (FDG) recommending AQUIPTA® (atogepant), an oral tablet, as an option for the acute treatment of migraine with or without aura in adults, only if, for previous migraines: at least 2 triptans were tried and they did not work well enough, or triptans were contraindicated or not tolerated, and nonsteroidal anti-inflammatory drugs (NSAIDs) and paracetamol were tried but did not work well enough.¹

Explore ACNR headache content

Migraine is a long-term health condition affecting around 10 million adults in the UK, yet it remains widely misunderstood as merely a headache.³⁻⁴ Characterised by a range of symptoms — including recurrent moderate-to-severe throbbing or pulsating head pain, nausea, vomiting and sensitivity to light and sound — migraine can disrupt daily life and prevent people from carrying out their daily activities.⁴⁻⁵ Despite its prevalence and severity, many people report that their condition is dismissed or stigmatised; in a survey by the Migraine Trust in 2024, 89% of 2,028 people surveyed living with migraine reported that migraine had affected their mental health.⁶

Beyond the impact on individuals, migraine also has a significant impact on productivity in the UK, driving high levels of absenteeism and reduced performance at work. Its unpredictable and debilitating symptoms place real pressure on employees and employers, costing the UK economy approximately £8.8 billion each year in lost productivity due to absenteeism and presenteeism.⁷⁻⁸

Rob Music, CEO at the Migraine Trust, said: “Access to appropriate care for people with migraine can be seriously inconsistent, creating a postcode lottery. Many people with migraine tell us they have struggled to access treatments or had to wait a long time before they could see a specialist. This is concerning because those living with migraine typically try a number of medicines before finding what works best for them. That is why it is so important that there are a variety of treatments available and clinicians have clear guidance on how they should be prescribed. We therefore welcome today’s update from NICE, which adds an additional treatment option for eligible migraine patients.”

“The NICE recommendation means an additional treatment option for suitable individuals experiencing acute migraine attacks. This treatment option will allow clinicians to consider a wider range of approaches when managing acute migraine.”

Professor Alex Sinclair, Professor of Neurology at the University of Birmingham and Chair of The British Association for the Study of Headache (BASH) Council.

The recommendation is supported by data from ECLIPSE, the pivotal Phase 3 clinical study evaluating the safety, efficacy and tolerability of atogepant for the acute treatment of migraine.³ The study included adults with migraine with or without aura and a history of 2 to 8 migraine attacks of moderate to severe headache pain in each of the 3 months prior to screening or first visit. The acute study met its primary endpoint of percentage of patients achieving pain freedom at 2 hours post‑dose (first attack), with 24.3% of atogepant patients vs 13.1% of placebo patients achieving pain freedom at 2 hours (p<0.0001).³

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There were no individual treatment emergent adverse events (TEAEs) with an incidence ≥ 2% for the first attack in the double-blind period. The most frequent TEAEs (≥ 2%) during the double-blind period were nasopharyngitis (4.6%) and upper respiratory tract infection (2.3%).³

Rachael Millward, Medical Director, AbbVie UK, said: “Migraine is a complex neurological condition that can have a profound impact on quality of life, leading to social withdrawal and missed work. AbbVie remains committed to addressing the ongoing challenges faced by people living with this condition. This NICE recommendation will enable eligible patients in England and Wales access to an acute treatment option for the treatment of their migraine attacks.”

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References

  1. https://www.nice.org.uk/guidance/indevelopment/gid-ta11817%5BLast accessed: June 2026]
  2. AQUIPTA® (Atogepant) Summary of Product Characteristics. Available
    at: https://www.medicines.org.uk/emc/search?q=atogepant. Accessed May 2026
  3. Ashina M, et al. Efficacy, safety, and tolerability of atogepant for the acute treatment of migraine: results from the ECLIPSE study. Presented at the European Headache Congress, Lisbon, Portugal, December 3–6, 2025.
  4. The Migraine Trust. Stigma of migraine leading to thousands struggling without care. Available at:
    Stigma of migraine being ‘just a headache’ leading to thousands being dismissed and struggling without care – The Migraine Trust. Accessed May 2026.
  5. NHS. Migraine. Available at: Migraine – NHS. Accessed May 2026.
  6. NICE. What are the clinical features and diagnostic criteria for migraine (CKS). Migraine: diagnosis. Available
    at: Diagnosis | Diagnosis | Migraine | CKS | NICE. Accessed May 2026.
  7. The Migraine Trust. New research reveals devastating impact of living with migraine, yet condition still not taken seriously.
    Available at: New research reveals devastating impact of living with migraine, yet condition still not taken seriously – The Migraine Trust. Accessed May 2026.
  8. Lancaster University. 86 million workdays lost to migraine in the UK every year. Available at:
    86 million workdays lost to migraine in the UK every year | Lancaster University. Accessed May 2026.
  9. The National Migraine Centre. Migraine and work. Available at:
    http://www.nationalmigrainecentre.org.uk/corporate-wellbeing/migraine-and-work/. Accessed May 2026.
  10. The Migraine Trust. What is migraine? Available at: What is migraine? – The Migraine Trust. Accessed
    May 2026.
  11. Gupta J and Gaurkar SS. Migraine: an underestimated neurological condition affecting billions. 20240724-319105-m8q8ni.pdf.
  12. The Migraine Trust. Migraine without aura. Available at: Migraine without aura – The Migraine Trust. Accessed May 2026.
  13. Begasse de Dhaem O and Sakai F. Migraine in the workplace. Migraine in the workplace – ScienceDirect.
  14. The Migraine Trust. Heading in the wrong direction: challenges in migraine care and why people with migraine deserve
    better. Available at: TMT-Heading-In-The-Wrong-Direction-2023-FINAL.pdf Accessed May 2026.
  15. NHS RightCare. RightCare: Headache & Migraine Toolkit optimising a headache and migraine system. Available
    at: https://www.england.nhs.uk/rightcare/wp-content/uploads/sites/40/2020/01/rightcare-headache-and-migraine-toolkit-v1.pdf
  16. Ferrari MD, et al. Migraine. Nat Rev Dis Primers 2022;8:2.
  17. Ashina M, et al. Once-daily oral atogepant for the long-term preventive treatment of migraine: Findings from a multicenter,
    randomized, open-label, phase 3 trial. Headache 2023;63:79–88.
  18. Ailani J, et al. Atogepant for the preventive treatment of migraine. N Engl J Med 2021;385:695–706.
  19. Pozo-Rosich P, et al. Atogepant for the preventive treatment of chronic migraine (PROGRESS): a randomised, double
    blind, placebo-controlled, phase 3 study. Lancet 2023;402:775–785.

Lancet Neurology Consensus Unveils CBI-M Framework to Replace Traditional TBI Silos

Posted on May 21, 2026 by - Acquired Brain Injury

Expert commentary provided by Dr Phil Moore, Consultant Neuropsychologist/Clinical Psychologist, UK.

For half a century, the Glasgow Coma Scale has served as the universal shorthand for brain injury, but its rigid categories of “mild, moderate, and severe” are increasingly viewed as an oversimplification of a complex reality. A landmark international consensus published in The Lancet Neurology marks a turning point in this history, proposing the CBI-M model—a multidimensional framework designed to move neurocritical care into the era of precision medicine. By moving beyond a single, static triage score, this new approach offers a more granular foundation for long-term neurorehabilitation.

The CBI-M model is built upon four distinct pillars that replace traditional labels with a dynamic assessment. The Clinical pillar shifts the focus from a single admission snapshot to a 14-day tracking period of neurological data. This is bolstered by the Biomarker pillar, which introduces blood-based assays to detect microscopic cellular stress that standard CT scans often miss. Meanwhile, the Imaging pillar utilises advanced neuroimaging to map physical tissue damage, while the Modifiers pillar factors in the individual’s unique context—such as genomics, age, and pre-existing health—to forecast a more realistic recovery trajectory.

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For professionals in neurology and neurorehabilitation, this paradigm shift promises a move away from “one-size-fits-all” protocols toward deeply targeted interventions. By using objective data to set individualised goals, clinicians can better identify patients who might have been dismissed as “mild” cases but actually harbour significant structural risks. It represents a transition from simply describing an injury to understanding its specific mechanics within a specific person.

However, the path to implementing CBI-M within the UK’s National Health Service is fraught with structural hurdles. Most NHS labs do not yet have the infrastructure for routine TBI biomarker testing, and the high demand for MRI and CT scans remains a significant bottleneck. Furthermore, UK clinicians are bound by NICE guidelines that still mandate the use of the GCS. There is also a looming risk of a “postcode lottery,” where only major neuroscience centres have the resources to adopt these high-tech tools. Perhaps most critically for rehab specialists, the model’s focus on the first 14 days may miss the many UK patients who only seek help weeks after a seemingly minor injury.

Ultimately, while CBI-M offers a revolutionary roadmap for brain injury management, its arrival on UK wards will require substantial funding and a total overhaul of national regulatory standards.

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Bial launches KYNMOBI in the UK for Parkinson’s OFF episodes

Posted on January 8, 2026 by - Industry News, Movement Disorders, Parkinson’s Disease

Bial has announced the launch of KYNMOBI (apomorphine hydrochloride) in the United Kingdom, introducing the first sublingual film for the intermittent treatment of uncontrolled OFF episodes in adults with Parkinson’s disease whose symptoms are not adequately controlled by oral anti-Parkinson medication.

Around 166,000 people in the UK are estimated to be living with Parkinson’s disease, and many will experience OFF episodes during the course of their illness. These episodes occur when medication, most commonly levodopa, becomes insufficient throughout the day, leading to the return or worsening of motor symptoms such as stiffness, tremor and difficulty moving. OFF periods can have a substantial impact on daily functioning, independence and wellbeing. In this context, rescue treatments used alongside regular medication are considered important for the rapid, on-demand relief of symptoms.

KYNMOBI is delivered as a sublingual film placed under the tongue and held in position until it dissolves completely. This method of administration avoids the first-pass effect associated with oral therapies and supports a rapid onset of action. The availability of a sublingual formulation represents a new way of delivering a well-established treatment option for people experiencing intermittent OFF episodes.

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The efficacy and safety of sublingual apomorphine have been demonstrated in two Phase III clinical studies. In a double-blind, placebo-controlled trial, treatment resulted in a statistically significant improvement in motor function, measured by the MDS-UPDRS Part III score at 12 weeks, compared with placebo. A higher proportion of patients also achieved a subject-rated full ON response within 30 minutes of dosing. In a second open-label, randomised crossover study, sublingual apomorphine showed therapeutic efficacy comparable to subcutaneous apomorphine, with numerically similar improvements in motor scores following treatment.

“I am delighted to see Kynmobi becoming available as another therapeutic option in the UK for Parkinson’s disease. It is by having a breadth of therapies to select from that we, as clinicians, are able to provide care personalised to the requirements and preferences of patients. It is particularly pleasing to see a new formulation coming through to market based on trials that UK sites helped to deliver. By actively engaging with research opportunities and supporting trial delivery we can all ensure that people with Parkinson’s continue to benefit from innovative therapies.”

Camille Carroll, Consultant Neurologist and Professor of Clinical Neuroscience at the Translational and Clinical Research Institute at Newcastle and Faculty of Health, University of Plymouth

Across pooled Phase II and Phase III studies, the most commonly reported adverse reactions included nausea, somnolence and dizziness. Oropharyngeal adverse events such as swelling, irritation and ulceration were also commonly observed in patients treated with sublingual apomorphine.

Bial stated that the UK launch follows a decentralised European approval process and reflects the company’s ongoing commitment to people living with Parkinson’s disease and to strengthening its position in neurology across Europe.

This news item has been summarised using AI and checked by humans before publication.

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Sources
Bial press release

Kynmobi (apomorphine hydrochoride) – Summary of Product Characteristics – available on www.medicines.org.uk (last accessed: December 2025)

Parkinson’s UK – Parkinson’s statistics; available on www.parkinsons.org.uk/about-us/parkinsons-statistics (last accessed: December 2025)

Lung-brain cancer connection

Posted on December 16, 2025 by - Neuro oncology

Researchers have uncovered an unexpected and potentially transformative mechanism behind small cell lung cancer, revealing that the disease can directly hijack neural circuits in the brain to fuel its growth.

Two independent research teams, working in Germany and the United States, discovered that small cell lung cancer cells form functional synapses with neurons, allowing them to receive electrical and chemical signals normally reserved for brain cells. The studies, published simultaneously in Nature, challenge long-held assumptions about how cancers outside the brain behave once they spread to neural tissue.

The discovery began with genetic screens in mouse models of small cell lung cancer, a disease responsible for around 15 percent of lung cancer cases worldwide and associated with extremely poor survival. Unexpectedly, researchers repeatedly identified genes linked to synapse formation, neurotransmission, and neural signalling, features that appeared biologically implausible in lung tumours. Parallel work in neuro-oncology reached the same conclusion from the opposite direction, asking whether cancers with neuroendocrine features could exploit the same neural mechanisms previously described in brain tumours.

Using advanced imaging and viral tracing techniques, both teams demonstrated that cancer cells form classical synapses with neurons. These connections enable glutamate-driven electrical activity and calcium signalling within tumour cells, directly stimulating proliferation and tumour progression. Experimental manipulation showed that activating neurons increased cancer growth, while directly triggering electrical activity within tumour cells caused tumours to expand rapidly.

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The findings help explain the aggressive nature of small cell lung cancer and its strong tendency to metastasise to the brain. They also point to a promising therapeutic opportunity. In animal models, existing neurological drugs that interfere with synaptic signalling, including treatments used for epilepsy and amyotrophic lateral sclerosis, slowed tumour growth and extended survival when combined with standard chemotherapy.

Researchers caution that clinical evidence in humans is still lacking, but early planning for trials is under way. The work also raises concerns that some commonly prescribed neurological medications could unintentionally accelerate tumour growth by enhancing synaptic activity.

By revealing that small cell lung cancer can co-opt the brain’s own communication systems, the studies open a new field of cancer neuroscience and suggest a novel strategy for targeting one of the deadliest malignancies.

This news item has been summarised using AI and checked by humans before publication.

References

Functional synapses between neurons and small cell lung cancer | Nature
Neuronal activity-dependent mechanisms of small cell lung cancer pathogenesis | Nature


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Blarcamesine Anavex marketing authorisation refused by EMA for Alzheimer’s disease

Posted on December 12, 2025 by - Alzheimer's Disease, Dementia

The European Medicines Agency (EMA) has recommended refusing marketing authorisation for Blarcamesine Anavex, a proposed treatment for Alzheimer’s disease, following a negative opinion adopted on 11 December 2025. The applicant company, Anavex Germany GmbH, can request a re-examination within 15 days of receiving the opinion.

Blarcamesine Anavex contains blarcamesine (as blarcamesine hydrochloride) and was intended to be supplied as hard capsules, to be used in addition to other treatments. During the evaluation, the company proposed narrowing the target population to adults with early Alzheimer’s disease, either mild cognitive impairment due to Alzheimer’s disease or early-stage mild dementia due to Alzheimer’s disease, specifically in people without a SIGMAR1 gene mutation.

The proposed mechanism of action was activation of the sigma-1 receptor protein, with the aim of supporting nerve cell function and reducing damage linked to inflammation, in turn slowing cognitive decline.

The application relied mainly on results from a 48-week study involving 462 adults aged 60 to 85 years with early Alzheimer’s disease, comparing blarcamesine with placebo. The co-primary outcomes assessed change in cognition using ADAS-Cog13 and change in ability to perform daily activities using ADCS-ADL, alongside subgroup analyses including participants without SIGMAR1 mutations.

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EMA concluded that the main study did not demonstrate effectiveness and safety in the proposed SIGMAR1 non-mutation subgroup. The trial did not meet its main objective of showing improvement across both primary measures, and EMA highlighted methodological issues that raised concerns about the validity of the results, preventing a positive conclusion on efficacy. On safety, EMA cited limitations in the safety database and how safety data were collected, and noted a high proportion of treatment discontinuations, mainly due to central nervous system side effects, raising concerns about tolerability. EMA also identified quality concerns, stating that available information did not rule out the formation of nitrosamine impurities. Although the company applied for conditional marketing authorisation during the procedure, EMA said the criteria were not met and recommended refusal.

This news item has been summarised using AI and checked by humans before publication.

Sources
ema.europa.eu

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