Here is our regular summary of content of relevance to neurology from the Human Medicines Highlights – July 2026
Key EMA News Updates:
- Patients’ and Consumers’ Working Party marks 20th anniversary
The EMA celebrated the 20th anniversary of its Patients’ and Consumers’ Working Party, reflecting on two decades of patient and consumer engagement in medicines regulation and discussing future priorities. Click here for more details: EMA – The Patients and Consumers’ Working Party Celebrates its 20th Anniversary
- EMA strengthens focus on women’s health
The EMA has launched new initiatives to identify gaps and prioritise actions to better integrate women’s health considerations into medicines development and regulatory decision-making. Click here for more details: EMA steps up efforts on medicines for women’s health | European Medicines Agency (EMA)
- EMA publishes 2025 annual report
The EMA’s 2025 annual report highlights the agency’s key achievements in the evaluation and monitoring of human and veterinary medicines, including strong medicine approval figures. Click here for more details: EMA’s 2025 annual report shows strong approval numbers for human and veterinary medicines | European Medicines Agency (EMA)
- Inside EMA podcast – medicines in pregnancy and breastfeeding
The latest podcast episode explores the lack of evidence on medicine use during pregnancy and breastfeeding, and the EMA’s efforts to improve data generation and support informed treatment decisions. Click here for more details: Podcast: Inside EMA | European Medicines Agency (EMA)
- Highlights from the June 2026 Management Board meeting
The Management Board reviewed the EMA’s support for the Ebola outbreak response and received updates on the implementation of the new EU pharmaceutical legislation. Click here for more details: EMA Management Board: highlights of June 2026 meeting | European Medicines Agency (EMA)
New medicines recommended for approval:
- Hopledo (levodopa / carbidopa) – The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the granting of a marketing authorisation for Hopledo, intended for the treatment of adults with Parkinson’s disease and moderate-to-severe motor fluctuations who have not been sufficiently stabilised with oral levodopa/dopa decarboxylase (DDC) inhibitor-based treatment regimens. Hopledo will be available as 140 mg/35mg, 210mg/52.5mg, 280mg/70mg and 350mg/87.5mg modified-release hard capsules. The capsules contain immediate-release granules and extended-release beads. Click here for more details: Hopledo | European Medicines Agency (EMA)
New information on authorised medicines:
- Vyndaqel (tafamidis) – Co-administration of tafamidis meglumine with substrates of the breast cancer resistance protein (BCRP) may increase exposure to the BCRP substrate. When co-administered, patients should be monitored for BCRP substrate-related adverse reactions, and dose reduction of the BCRP substrate may be considered. Click here for more details: Vyndaqel | European Medicines Agency (EMA)
Supply shortages:
- Tegsedi (inotersen) – Tegsedi will be unavailable in the EU from the end of 2026. It is indicated for the treatment of stage 1 or 2 polyneuropathy in adults with hereditary transthyretin amyloidosis (hATTR). The marketing authorisation holder, Akcea Therapeutics Ireland Ltd., has decided to permanently discontinue the medicine for commercial reasons, primarily due to its low use following the availability of alternative treatment options. The discontinuation is not related to any quality defect or safety concern. Click here for more details: Tegsedi – supply shortage | European Medicines Agency (EMA)
- Topamax (topiramate) – There is currently a shortage of Topamax tablets in the EU/EEA. Topamax is indicated for the treatment of epilepsy in adults, adolescents, and children over two years of age. The shortage is due to manufacturing issues, following the identification during a routine assessment of the need to modify engineering controls and internal environmental technologies at a manufacturing site, resulting in a temporary interruption of production. The shortage is not related to any quality defect or safety concern and is expected to continue until the end of 2026. Click here for more details: Topamax – supply shortage | European Medicines Agency (EMA)
Direct Healthcare Professional Communication (DHPC)
- Evrysdi (risdiplam) – A Direct Healthcare Professional Communication (DHPC) has been issued following reports of visible insoluble white PTFE (Teflon) particles in reconstituted Evrysdi 0.75mg/mL oral solution from two batches (B2033B03 and B2035B09), indicated for the treatment of spinal muscular atrophy (SMA). PTFE is chemically inert and is not expected to be absorbed, and the clinical risk is considered low. No adverse events or safety signals have been linked to this issue. Healthcare professionals should visually inspect the reconstituted solution before dispensing. If visible particles are present, the bottle should not be dispensed and should be promptly replaced to ensure treatment continuity. Click here for more details: Evrysdi – direct healthcare professional communication (DHPC) | European Medicines Agency (EMA)
