Here is our regular summary of content of relevance to neurology from the Human Medicines Highlights – September 2026
Key EMA News Updates:
- New EU supply chain to address Visudyne shortage
A new EU supply chain for Visudyne (verteporfin), used to treat serious eye conditions, marks an important step towards resolving the medicine’s long-standing shortage. Click here for more details: New EU supply chain to end Visudyne shortage | European Medicines Agency (EMA)
- Visual abstracts introduced for DARWIN EU studies
The EMA is now providing visual abstracts for all new DARWIN EU studies using real-world data, making study results easier to understand and access. The abstracts are available on the webpages of the finalised studies in the HMA-EMA catalogues. Click here for more details: Search | HMA-EMA Catalogues of real-world data sources and studies
- Emer Cooke speaks on the future of medicines regulation
EMA Executive Director Emer Cooke discussed the future of medicines regulation in a speech at Duke-NUS Medical School in Singapore as part of the Sir Alasdair Breckenridge Lecture Series. Click here for more details: Executive Director’s speech at Duke-NUS Medical School in Singapore | European Medicines Agency (EMA)
- New pilot to advance alternatives to animal testing
The EMA launched a voluntary data submission pilot allowing developers to share data generated using new approach methodologies (NAMs) and receive feedback, supporting efforts to replace or reduce animal studies in non-clinical medicine development. Click here for more details: Voluntary data submission pilot to advance innovative alternatives to animal testing | European Medicines Agency (EMA)
- EMA concludes review of ipidacrine-containing medicines
The EMA concluded its review of ipidacrine-containing medicines, finding that their benefits continue to outweigh the risks while recommending important restrictions on their use. Click here for more details: EMA concludes review of ipidacrine-containing medicines | European Medicines Agency (EMA)
- Sodium oxybate benefits continue to outweigh risks in alcohol dependence
The EMA concluded that the benefits of sodium oxybate medicines continue to outweigh their risks when used in people with alcohol dependence, while additional studies are required to further characterise their efficacy for these uses. Click here for more details: Benefits of sodium oxybate continue to outweigh risks in people with alcohol dependency | European Medicines Agency (EMA)
Medicines:
- Ocrevus (ocrelizumab) – extension of indication
On 17 September 2026, the Committee for Medicinal Products for Human Use (CHMP) recommended extending the indication to paediatric patients aged ≥10 years with active relapsing forms of multiple sclerosis, defined by clinical or imaging features. Click here for more details: Ocrevus – opinion on variation to marketing authorisation | European Medicines Agency (EMA)
- Isembyld (apitegromab)
On 13 August 2026, Scholar Rock Netherlands B.V. withdrew its application for marketing authorisation of Isembyld (apitegromab) for the treatment of 5q spinal muscular atrophy (SMA). Apitegromab is a monoclonal antibody designed to bind to inactive (pro- and latent) forms of myostatin, thereby promoting muscle growth. Click here for more details: Isembyld | European Medicines Agency (EMA)
- Ipidacrine-containing medicinal products – safety review
The CHMP is reviewing the benefit–risk balance of ipidacrine, an acetylcholinesterase inhibitor nationally authorised in several EU/EEA countries for various neurological conditions, following concerns regarding limited evidence of efficacy and potential hepatotoxicity. The review will determine whether the existing marketing authorisations should be maintained, modified, suspended or revoked. Click here for more details: Ipidacrine-containing medicinal products – referral | European Medicines Agency (EMA)
