US regulator finally grasps aducanumab

After first pledging to file aducanumab in early 2020 Biogen today revealed that it had only now submitted the controversial Alzheimer’s disease project to the US FDA, sending shares up 5%. The FDA now has 60 days to accept or reject the filing and decide whether to grant priority review. And here lies the rub: there are questions around Biogen’s data package, including missing data values and a less than convincing efficacy profile. An advisory committee will no doubt be called to scrutinise the toxicity profile and statistical rigour of aducanumab's clinical programme. However, given the paucity of Alzheimer’s treatments and an FDA that has shown leniency towards treatments for intractable diseases with no other options, aducanumab’s filing looks likely to be accepted. Beyond aducanumab Biogen’s pipeline is thin, and a patent loss for Tecfidera last month deepened the company’s reliance on the Alzheimer’s project. Roche and Lilly have both spent years trying to gain ground with their own beta amyloid-targeting MAbs, and will surely keep a close eye on the regulator’s proceedings.