FDA and Bio­gen dis­cussed Aduhelm's ac­cel­er­at­ed ap­proval as ear­ly as 2019 — re­port

Top FDA neu­ro­science of­fi­cial Bil­ly Dunn has been a vo­cal ad­vo­cate for Bio­gen and its Alzheimer’s drug Aduhelm through­out the en­tire re­view process all the way up to the drug’s di­vi­sive ac­cel­er­at­ed ap­proval. That en­thu­si­asm — which had drawn the ire of ad­vo­ca­cy groups and the ad­comm of out­side ex­perts — seems to stem from a se­ries of meet­ings be­tween the com­pa­ny and Dunn dat­ing back as far as 2019, STAT re­ports, when the Cam­bridge, MA drug­mak­er launched a se­cret cam­paign dubbed Project Onyx to win ap­proval for ad­u­canum­ab.

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