Biogen meets after Alzheimer’s drug fails to win FDA panel assist

Biogen headquarters on Binney Street on Thursday, March 21, 2019 in Cambridge, Massachusetts.

Nicolaus Czarnecki | MediaNews Group | Getty Images

A Food and Drug Administration panel unexpectedly declined on Friday to endorse Biogen’s experimental Alzheimer’s drug aducanumab as a setback for the pharmaceutical company.

In an 8: 1 vote, the panel said Biogen’s late-stage study did not provide “strong evidence” that aducanumab was effective in treating Alzheimer’s disease. Two other panellists said the data was “uncertain”.

The FDA could still approve the drug. It would be the first drug approved to slow cognitive decline in people with the disease, and the first new treatment for Alzheimer’s in almost 20 years.

Biogen’s shares were halted on Friday before the meeting of outside experts.

Biogen stocks were up on Wednesday after FDA officials rated the drug positively. In a 343-page document, the FDA said the results of the late-stage Biogen study were “very compelling” and that the study was “able to do the mainstream in demonstrating substantial evidence” of aducanumab. “Based on the above considerations, the applicant has presented substantial evidence of efficacy in support of the approval,” added the FDA.

Alzheimer’s disease is a progressive neurodegenerative disorder that slowly destroys memory and the ability to think. The Alzheimer’s Association estimates that more than 5 million Americans are living with the disease.

Biogen’s intravenous drug targets a “sticky” compound in the brain known as beta-amyloid, believed to be involved in the devastating disease. According to Reuters, Biogen estimates that around 1.5 million people with early-stage Alzheimer’s could be candidates for the drug in the United States.

Some Alzheimer’s experts and Wall Street analysts were skeptical of the drug’s benefits, especially after Biogen reversed its decision to file for regulatory approval in 2019.

The company shocked investors in October this year when it announced that it is still seeking regulatory approval after unplugging the drug in March. Biogen scientists said at the time that a new analysis of a larger data set showed that aducanumab “reduced clinical decline in patients with early Alzheimer’s disease.”

There are currently no FDA-approved drugs that can slow or reverse the mental decline of Alzheimer’s, the sixth leading cause of death in the United States. The US agency has approved Alzheimer’s drugs that are designed to relieve symptoms without reversing or slowing the disease itself.

During Friday’s meeting with the Advisory Committee on Drugs for the Peripheral and Central Nervous System, Dr. Billy Dunn, director of the neuroscience office at the FDA’s Center for Drug Evaluation and Research, said there was “an enormous unmet medical need.”

“Currently approved treatments do not target the underlying pathology of Alzheimer’s disease and their beneficial effects are modest,” he said, adding that there has been no approval for a treatment for the disease since 2003.

In a letter to the FDA prior to the meeting, the Alzheimer’s Association said the data released so far “warrant approval, which will be accompanied by a phase 4 post-market surveillance study”.

“The alternative, which requires the completion of an additional Phase 3 study, would deny broad access for up to four years while it is complete. A four-year delay is too long to wait for millions of Americans to join facing a progressive, deadly disease. The one year delay is too long to wait for millions of American caregivers, “the organization said.

The FDA’s final decision on Biogen’s drug is expected by March.

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