Biogen is set to provoke an early pointer of the direction the FDA will take under new Commissioner Stephen Hahn. Having made the shock decision to resurrect aducanumab after it failed a phase 3 futility analysis, Biogen is set to file for FDA approval of the Alzheimer’s disease drug next year.
The submission will be a test of how far Hahn’s FDA is willing to diverge from its established approval standards. Under U.S. law, companies need to show “substantial” evidence of effectiveness to win approval. Biogen will arrive at the FDA with results from one trial that suggest aducanumab is no better than placebo and data from another that link it to improved scores on a dementia scale.
Biogen and some physicians think the overall data set shows aducanumab works. Many analysts are more skeptical, arguing that Biogen’s data, which even its supporters admit are complex, are too weak to constitute “substantial” evidence.
Under Hahn’s predecessor, the FDA approved drugs on the basis of evidence that many outsiders saw as insubstantial, but those products typically targeted rare diseases. Alzheimer’s is on a different scale entirely. Other companies will be closely watching how Hahn’s FDA handles the chance to finally get a new treatment to Alzheimer’s patients.