Accelerated Approval Not Enough To Threaten Breakthrough Status

By John Wilkerson / June 29, 2022 at 5:43 PM
FDA probably would not rescind a “breakthrough therapy designation” for a drug if another drug for the same unmet need were granted accelerated approval, according to draft guidelines published June 21. The policy is consistent with decades of FDA practice, sources say, though a Harvard professor says the policies for accelerated approval and breakthrough designation are inconsistent. Accelerated approval policy got tied up in the debate over drug prices when Biogen slapped a $56,000 price tag on Aduhelm following its...

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.