(Reuters) – The European Union’s medicines regulator on Friday reiterated its positive recommendation for Eisai and Biogen’s Alzheimer’s drug, Leqembi, after concluding a safety review. The European Medicines Agency (EMA) in late January said the European Commission had requested a review of additional safety information for the drug, following its November approval to treat some patients with early Alzheimer’s disease.
The Commission, which is EU’s executive arm, must accept EMA recommendations for new drugs before they are made available to patients. It did not say why it had requested a safety review for Leqembi.
Biogen’s head of development, Priya Singhal, said the “reaffirmation” underscores Leqembi’s safety profile, adding that the company was working with Eisai to make the treatment available to patients in Europe as soon as possible.
The EMA’s human medicines committee last year backed Leqembi for a narrower set of patients than those evaluated in a late-stage trial, reversing its initial refusal to approve the drug due to the risk of serious brain swelling.
Leqembi can cause brain swelling or bleeding, and patients must also undergo an MRI before treatment and several during treatment to monitor this risk, according to the U.S. Food and Drug Administration.
The therapy, also known as lecanemab, is already approved in the U.S., China, Hong Kong, Israel, Japan and South Korea, and could become Europe’s first drug approved to treat the neurodegenerative condition directly rather than treat its symptoms.
(Reporting by Christy Santhosh in Bengaluru; Editing by Tasim Zahid, Sriraj Kalluvila and Shailesh Kuber)
