Biogen submits FDA application for closely watched Alzheimer’s drug

July 8, 2020

Biogen and Eisai have submitted a marketing application to the FDA for an Alzheimer’s drug that’s become a target of skepticism by many market analysts.

In March of 2019, Biogen released data from two late-stage trials for aducanumab, an experimental monoclonal antibody developed to help slow cognitive and functional decline. But the results on patients with early or mild Alzheimer’s were iffy — in one study, patients who received a high dose scored better on a dementia scale. Then in a second phase 3 trial, those same patients fared worse compared to those on a placebo. Ultimately, the mixed results, along with a failed futility analysis, caused Biogen to end the research. 

Then in October, Biogen made a surprise announcement that a reanalysis of the data revealed that aducanumab was effective at a high dose over an extended period of time. The company then said it would pursue FDA approval. 

If given the green light, Biogen says that aducanumab would be the “first treatment to meaningfully change the course of the disease for individuals living with Alzheimer’s.” 

But not everyone is convinced. One analyst from Baird wrote a note to investors in December expressing doubt that aducanumab will meet the FDA’s standard for efficacy because the data indicates it doesn’t “provide clinical benefit.”

The FDA now has 60 days to decide if it will accept the companies’ application for review. Biogen and Eisai have asked for a priority review, which could reduce the approval time wait to six months. 

Read the full Reuters report.