BUSSLES: The European Union’s drug regulator on Thursday said it recommended approval of Biogen’s Eisai 4523.T and BIIB.O Leqembi in patients with early-stage Alzheimer’s disease, months after the agency This first time refused this treatment.
The agency’s Committee on Human Medicines (CHMP) said it recommended approval of the drug for patients with only one or no copy of the ApoE4 gene, which is associated with earlier onset of the disease.
In this restricted population, the committee said the benefits of Leqembi in slowing the progression of the disease’s symptoms outweigh its risks.
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The CHMP opinion is an intermediate step on Leqembi’s path to reaching patients. This opinion will now be sent to the European Commission for adoption of a decision on EU-wide marketing authorization.
Once a marketing authorization has been granted, pricing and reimbursement decisions will take place at the level of the individual member state, taking into account the potential role and use of the medicine in the systemic context national health of that country.
In July, the agency denied approval of the drug, saying the risk of serious brain swelling did not outweigh its small effect in slowing cognitive decline.
Biogen did not immediately respond to a request for comment.