Roche mulling quick fil­ing for a tar­nished Alzheimer’s drug as con­tro­ver­sial Aduhelm OK elec­tri­fies the field — an­a­lyst

It’s in­creas­ing­ly un­clear just how long Bio­gen will have the on­ly ma­jor Alzheimer’s drug on the mar­ket.

Ac­cord­ing to a re­port from Jef­feries, Roche has been in dis­cus­sions with the FDA on whether they can file their own Alzheimer’s drug for ac­cel­er­at­ed ap­proval in the com­ing months, fol­low­ing a path­way the FDA opened with their con­tro­ver­sial de­ci­sion to ap­prove Bio­gen’s Aduhelm. That would be more than a year ahead of when Roche had orig­i­nal­ly hoped to file it and be­fore the com­pa­ny got back da­ta from their Phase III tri­als test­ing whether the drug can ac­tu­al­ly slow cog­ni­tive de­cline.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER