EMA’s CHMP reaffirms its decision to back Leqembi for Alzheimer’s
Regeneron’s bispecific, Krystal’s gene therapy, and 16 label extensions also among positive opinions issued at committee’s February meeting
The three new medicines recommended at this month’s meeting of EMA’s CHMP include a bispecific T T cell engager and a gene therapy., while the committee reaffirmed its positive opinion on Leqembi after an additional re-examination that involved new safety information.
The latest twist in the anti-amyloid drama went in favor of Eisai Co. Ltd. (Tokyo:4523) and Biogen Inc. (NASDAQ:BIIB), with CHMP deciding to move ahead with its positive opinion for Leqembi lecanemab in the narrower indication it had landed on after the last re-examination. Last month, the agency made the unusual move of agreeing to re-open its assessment of the Alzheimer’s therapy in light of new safety data. It has still not disclosed the nature of that but declared it is comfortable with its recommendation for approval in patients who carry zero or one APOE4 allele. Eisai had originally sought approval for all APOE genotypes, for which the drug is approved in the U.S...