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Phil Gutis aducanumab Alzheimer's FDA approval snag

FDA Delays Aducanumab Decision

By Phil Gutis | February 1st, 2021

Biogen’s Alzheimer’s drug aducanumab encounters another bump in the road as the FDA delays its approval decision.

The Federal Drug Administration has given itself another three months to determine the fate of a much-herald Alzheimer’s drug. Instead of announcing a decision on whether it will approve Biogen’s aducanumab drug in March, as earlier promised, the agency said recently that its decision will be delayed until June 7, 2021.

The announcement from the FDA marks the latest twist and turn for the drug, which has been through the proverbial ringer in recent years. And depending on who you listen to, the latest delay is either a positive signal or a sign of doom.

In a news release, Biogen and its partner Eisai Co. thanked the FDA for its “continued diligence” and said the “extended review period” is the result of new data submitted to the federal agency. 

“We are committed to working with the FDA as it completes its review of the aducanumab application,” said Michel Vounatsos, Chief Executive Officer at Biogen. “We want to thank the FDA for its continued diligence during the review.”

Biogen stock jumped on the FDA’s decision. Some market analysts greeted the delay with optimism, saying that if the FDA weren’t interested in approving the drug, it could have simply rejected it last week. Instead, analysts at Jefferies said that “we think minor delays typically lead to an approval since the parties tend to figure out the last remaining items of a filing.”

But Bloomberg reported that FDA watchers and staff “worry that the regulator and its leadership may be developing a pattern of approving drugs of questionable value for devastating conditions because of public pressure.”

The magazine cited the FDA’s quick authorization of COVID-19 treatments such as hydroxychloroquine that were later deemed failures.

Last year, an FDA advisory committee rejected data presented by Biogen scientists and FDA staff along with the pleas of people living with Alzheimer’s and other advocates for the drug’s approval. The advisory committee said that it remained unpersuaded that aducanumab helps slow the development of Alzheimer’s.

The FDA is not obligated to follow the advice of its advisory panels, although it typically does.

In a letter to its advocates, the Alzheimer’s Association said it was “encouraged” by the FDA’s latest decision, adding that in a letter that it “appreciates the thoughtful and rigorous review of scientific data and analysis by the FDA.”

“We believe the publicly released scientific data, the crushing realities faced by individuals and families living with Alzheimer’s and, no approved treatment for the underlying disease, support FDA approval of aducanumab accompanied by a Phase 4 post marketing surveillance study,” Association President Harry Johns wrote.

Initially introduced in early stage trials in 2016, aducanumab entered its phase three trials with high hopes for success. 

But in March 2019, Biogen and its partner Eisai Co. stunned the Alzheimer’s community when they abruptly halted the drug’s development after aducanumab failed a “futility analysis.”

The companies then reversed their stance in October 2019, saying that late-arriving data had actually shown improvements for people living with mild cognitive impairment or very early Alzheimer’s. 

In December 2019, at a packed conference in San Diego, Biogen said that patients who received aducanumab experienced significant slowing of decline on measures of cognition and functions such as memory, orientation and language and said that it would seek FDA approval to market the drug.

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