Biogen, Eisai's filing for aducanumab in Alzheimer's disease nabs FDA priority review

Biogen and Eisai said Friday that the FDA accepted and granted priority review to a filing seeking approval of aducanumab for Alzheimer's disease, setting a target action date of March 7 next year. The companies noted that the agency also intends to hold an advisory committee meeting to discuss the submission, adding that if possible, the regulator "plans to act early" on the application. Biogen's shares climbed as much as 11% on the news.

Still, analyst Michael Yee of Jefferies remarked "we largely view an advisory committee as one of the big 'clearing events' and predict it will be 'mixed,' leaving the Street in limbo." Meanwhile, Stifel's Paul Matteis indicated "there still are a ton of questions surrounding the aducanumab dataset."

Last month, Biogen announced that it completed the filing to the FDA, noting at the time that it had requested a priority review of the anti-amyloid beta drug candidate. On Friday, Biogen also said it did not use a priority review voucher, gained following the approval of the spinal muscular atrophy treatment Spinraza (nusinersen) in 2016, for the aducanumab application. The company had not previously specified how it would use the voucher or when.

For related analysis, see ViewPoints: Clock is officially ticking on aducanumab.

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