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.

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