(Reuters) – The European medicines regulator said on Friday it will review safety information for Eisai and Biogen’s Leqembi, nearly three months after it recommended approval for the drug to treat some patients with early Alzheimer’s disease.
The safety information was made available after the regulator’s recommendation and may require an update to its previous opinion of the drug, the agency said.
Any recommendations from EU’s regulator must be accepted by the European Commission before the drug is made available to patients.
The review, requested by the European Commission, further delays the entry of what could be the region’s first treatment for the brain-wasting condition. Leqembi has been under review in the region since January 2023.
The medicines agency expects to provide a response to the commission in February, but did not provide details on what safety data is being reviewed.
Eisai and Biogen said that no new safety signals have been identified with the drug. They said that Leqembi’s safety profile as seen after its launch in the United States, Japan and other countries was consistent with prior studies.
“We believe that the EC’s requests can be addressed with existing information,” the companies said, adding that they will continue to work closely with the regulator.
In November, the EU regulator’s human medicines committee had recommended approval for a narrower set of patients than those evaluated in Leqembi’s trial.
Patients with only one or no copy of a gene associated with earlier onset of Alzheimer’s, are less likely to experience brain swelling and potential bleeding, the regulator had said at the time.
The approval recommendation had marked a reversal of the agency’s initial opinion of declining approval for the drug due to a risk of serious brain swelling.
(Reporting by Bhanvi Satija in Bengaluru; Editing by Shinjini Ganguli)
