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FDA advisory committee overwhelmingly votes no on Biogen's aducanumab

Path to approval looks increasingly difficult for potential Alzheimer’s treatment

A panel of outside experts met on Friday to examine data supporting Biogen’s new drug application for its potential Alzheimer’s treatment aducanumab, and the outcome was not positive.

The Peripheral and Central Nervous System Drugs Advisory Committee overwhelmingly voted no on a number of counts regarding the efficacy and evidence supporting the use of aducanumab in Alzheimer’s disease (AD).

In response to the question of whether two studies – EMERGE and ENGAGE – provide ‘strong evidence’ that aducanumab is effective at treating AD, eight experts voted no – with one voting yes and two ‘uncertain’.

In the EMERGE study, patients who received the highest dose of aducanumab demonstrated a statistically significant improvement on a clinical dementia scale.

In the ENGAGE study, which despite being of ‘identical design’ to the EMERGE study, the drug didn’t show clinical efficacy, and patients who received the highest dose of Biogen’s drug actually did worse than those on the placebo arm.

Aside from the two phase 3 studies, Biogen also submitted data from a phase 1b trial – PRIME – to support its aducanumab application.

The panelists were no more convinced by this early-stage data, however, with none of the experts voting yes when faced with the question of whether the PRIME results supported evidence of aducanumab’s efficacy.

On another question – “has the applicant presented strong evidence of a pharmacodynamic effect of aducanumab on Alzheimer’s disease pathophysiology?” – five experts voted yes, while six voted uncertain, representing a small win for Biogen.

"Biogen thanks the many patients and advocates who shared their personal thoughts and experience at today’s Advisory Committee meeting, reflecting the significant unmet need for a treatment for Alzheimer’s,” said Michel Vounatsos, chief executive officer at Biogen.

“We appreciated the opportunity to share our data with the Advisory Committee, and we will continue to work with the FDA as it completes its review of our application,” he added.

Although the FDA is not required to follow guidance from expert panel decisions, it usually does so.

If the FDA does follow the advice from the Advisory Committee, that could spell trouble for Biogen, which is currently facing a number of issues regarding its established brands, including its spinal muscular atrophy drug Spinraza (nusinersen) and multiple sclerosis treatment Tecfidera (dimethyl fumarate).

The FDA is set to announce its final decision on whether to approve aducanumab’s Biologics License Application (BLA) by 7 March 2021.

Article by
Lucy Parsons

9th November 2020

From: Regulatory



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