Tale Of Two Adcomms: US FDA Handling Of Entresto Data May Have Helped Avoid Aducanumab’s Fate

17 Dec 2020

Review divisions strongly encouraged filing of both the Novartis and Biogen drugs despite trials that missed their primary endpoints; with the heart failure drug, the agency took a more even-handed approach to presenting the data and was commended for its willingness to look beyond the narrowly missed p-value, in contrast to the barrage of criticism it faced with the Alzheimer’s drug.

night and day (shutterstock) — The advisory committee reviews of aducanumab and Entresto were as different as night and day. • Source: Shutterstock

The US Food and Drug Administration advisory committee review of a new heart failure indication for Novartis AG’s Entresto (sacubitril/valsartan) had the potential to be a repeat of the panel meeting on Biogen, Inc.’s Alzheimer’s drug aducanumab more than a month earlier.

As was the case with aducanumb, Novartis was coming to the panel with a trial that missed its primary endpoint....