By Bhanvi Satija
(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 respond to the commission in February, but did not provide details on what safety data is being reviewed.
Eisai also did not give details about what the safety data includes, but said that the information under review had already been examined by the U.S. Food and Drug Administration and UK’s medicines regulator.
No new safety signals have been identified with Leqembi, and its safety profile has not changed during or after EU’s review, the Japanese drugmaker said.
Leqembi’s safety profile as seen after its launch in the United States, Japan and other countries was consistent with prior studies, Eisai and partner Biogen said in a joint statement.
“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.
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)
