Analyst: Chances of FDA approving Biogen Alzheimer’s drug ‘just under a coin flip’

It’s been 17 years since the FDA reviewed an application for a new Alzheimer’s drug. And according to an analyst at RBC Capital Markets, the likelihood of Biogen winning a favorable review from an agency committee is not looking high.

Biogen stunned analysts by submitted an application for aducanumab in October — just months after the company announced it was abandoning the treatment following disappointing late-stage trial results. But Biogen said that after reexamining the study results, it found that patients receiving higher doses of the treatment showed improvements to cognition and function.

To help determine the chances that Biogen will now ultimately win approval, RBC hosted a mock advisory committee meeting involving medical practitioners who ultimately voted 6-2 against recommending approval. The panel said that the data does not “establish the efficacy” of the drug in patients with early stage Alzheimer’s.

 An analyst from RBC wrote in an investor note that the chances of the drug winning approval appear to be “just under a coin flip.” 

Yet, despite the skepticism about its efficacy, Biogen’s treatment has one major factor going for it — there’s little competition on the Alzheimer’s market and demand for new treatments is high.

One analyst from GlobalData noted that the agency isn’t likely to turn down aducanumab even if the advantages for patients are modest because of the lack of any treatment that is “truly efficacious.”

An FDA advisory committee is scheduled to review the data for aducanumab on Nov. 6.