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Regulation

Aducanumab panel criticizes FDA as it rebukes Alzheimer’s candidate 

Clear path to approval for Biogen’s aducanumab scuttled by FDA panel

FDA advisory committee muddies what appeared to be a clear and quick path to approval for Biogen’s aducanumab.

Nov 7, 2020 | 5:15 AM GMT

FDA’s advisers not only roundly rebuffed Biogen’s Alzheimer’s candidate aducanumab, tanking its odds of approval, they also lambasted the agency for bias in its presentation of the analyses.

In Friday’s meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) to discuss a BLA for the anti-amyloid therapy from Biogen Inc. (NASDAQ:BIIB), panel members voted 0-10 against the idea that the Phase III EMERGE study alone could reasonably be considered primary evidence of effectiveness of the mAb in light of supporting evidence from other studies. One panelist was undecided.

The result is another sharp turn in the roller coaster that has been aducanumab’s development. After failing for futility in March 2019, Biogen later reported that one of its two Phase III trials, EMERGE, met the primary cognitive endpoint.

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