(Reuters) -The European Union’s drugs regulator on Thursday said it recommends approval of Eisai and Biogen’s Leqembi in patients with early Alzheimer’s disease, months after the agency first rejected the treatment.
The agency’s human medicines committee (CHMP) said it recommends approval for the drug in patients who have only one or no copy of ApoE4 gene, which is linked with an earlier onset of the disease.
In this restricted population, the committee said benefits of Leqembi in slowing down progression of symptoms of the disease are greater than its risks.
The CHMP’s opinion is an intermediary step on Leqembi’s path to patient access. The opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation.
Once a marketing authorisation has been granted, decisions about pricing and reimbursement will take place at the level of each member state, taking into account the potential role and use of this medicine in the context of its national health system.
In July, the agency had rejected approval for the drug, saying the risk of serious brain swelling did not outweigh its small impact on slowing cognitive decline.
Biogen did not immediately respond to a request for comment.
(Reporting by Bhanvi Satija in Bengaluru and Julie Steenhuysen in Chicago; Editing by Maju Samuel)
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