Opinion: How the FDA bent its rules for Biogen’s Alzheimer’s drug and why that’s bad for the entire biopharma industry
The FDA’s stunning accelerated approval for Biogen’s Alzheimer’s drug Aduhelm, with limited clinical evidence supporting the decision, will have repercussions across the entire biopharma industry.
From companies now digging into new post-hoc analyses of failed trials, to others that can return to searching for amyloid beta-targeted drugs in search of a similar accelerated approval — when the bar is lowered for everyone, it’s the companies that put in the hard work to truly prove their drugs are safe and effective that will be hurt.
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