Skip to Main Content

Ahead of a widely anticipated regulatory review of Biogen’s experimental Alzheimer’s drug, a small survey found an overwhelming majority of physicians viewed the treatment favorably after combing through the briefing documents.

Specifically, 57% of the doctors believed Biogen (BIIB) presented strong evidence that its medicine, aducanumab, has a positive effect on Alzheimer’s. And 70% believe the Food and Drug Administration is more likely or significantly more likely to approve the drug based on the information that will be reviewed at the Friday advisory committee meeting.

Unlock this article by subscribing to STAT+ and enjoy your first 30 days free!

    • Hi MH,

      Thanks for the note. And that’s a fair point, although the survey also found that 61% believe Study 302 (EMERGE), when viewed independently and without regard for Study 301 (ENGAGE), provided strong evidence that supports the effectiveness of aducanumab for treating Alzheimer’s disease. And 70% believe Study 103 (PRIME) provides supportive evidence that the drug is effective. Of course, both were positive studies, so not a surprising response.

      In any event, slicing and dicing data is always debatable. I think the real context is the unmet medical need and how that sways views. Certainly, it’s an issue at the FDA. We’ll see what happens.

      ed at pharmalot

Comments are closed.