BioCentury
ARTICLE | Market Access

Viehbacher says two Biogen drugs likely launching into headwinds

The biotech’s CEO discusses the promise and the challenges ahead for Leqembi and zuranolone

March 6, 2023 11:57 PM UTC


Biogen has a lot riding on two upcoming product launches, but as it looks forward to FDA decisions on the therapies this summer, CEO Christopher Viehbacher acknowledges ramp up “is not going to be so easy” for either therapy.

Biogen Inc. (NASDAQ:BIIB) is hoping to offset the sagging revenues of its multiple sclerosis franchise with Alzheimer’s disease therapy Leqembi lecanemab-irmb and depression treatment zuranolone. Both products are under priority review. Leqembi has a July 6 PDUFA date on an application to convert its accelerated approval into a full approval, and zuranolone has an Aug. 5 PDUFA for both major depressive disorder and postpartum depression. Biogen expects FDA to hold an advisory committee meeting on Leqembi, though a date has yet to be announced...

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