Biogen headquarters is on Binney Street on Thursday, March 21, 2019 in Cambridge, Massachusetts.
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A Food and Drug Administration on Friday unexpectedly declined to confirm Biogen’s experimental aducanumab drug in a pharmaceutical company̵7;s setback.
In an 8-1 vote, the panel said the end-stage Biogen study did not provide “strong evidence” that aducanumab effectively treats Alzheimer’s disease. Two other panelists said the data was “uncertain.”
The FDA may still approve this drug, which would make it the first drug approved to slow cognitive decline in people living with the disease, and as a first-line treatment. first for Alzheimer’s after nearly 20 years.
Biogen shares were halted on Friday ahead of a meeting of outside experts.
Biogen shares surged on Wednesday after FDA staff gave a positive review of the drug. In a 343-page document, the FDA said the results from the Biogen end-stage trial were “highly convincing” and that the “study was likely to be a major contributor to demonstrating significant evidence of efficacy. “by aducanumab. “Based on the considerations above, the applicant provided substantial evidence of effectiveness to support approval,” the FDA added.
Alzheimer’s disease is a progressive neurodegenerative disorder that slowly destroys memory and thinking skills. The Alzheimer’s Association estimates more than 5 million Americans are living with the disease.
Biogen intravenous drugs target a “sticky” compound in the brain called beta-amyloid, is believed to play a role in the cause of malignancy. Biogen previously estimated that about 1.5 million people with early Alzheimer’s disease in the US could be candidates for the drug, according to Reuters.
Some Alzheimer’s disease experts and Wall Street analysts have questioned the benefits of the drug, especially after Biogen declined the decision to seek regulatory approval in 2019.
The company shocked investors in October of that year when it announced that it was seeking regulatory approval after unplugging the drug in March. Biogen scientists said at the time. That point is that a new analysis of a larger dataset suggests that aducanumab “reduces clinical decline in patients with early-stage Alzheimer’s disease.”
There are currently no FDA-approved drugs that can slow or reverse mental decline caused by Alzheimer’s disease, which is the sixth leading cause of death in the United States. The US Agency has approved Alzheimer’s drugs that are intended to help the symptoms, not actually reverse themselves or slow the disease.
During Friday’s meeting with the Central and Peripheral Nervous System Drugs Advisory Committee, Dr. Billy Dunn, director of the Office of Neuroscience at the FDA’s Center for Drug Research and Evaluation, said there was a “Great unmet medical need.”
“Currently approved treatments do not target the underlying disease of Alzheimer’s disease and their beneficial effects are modest,” he said, adding that since 2003, there hasn’t been any. Approval for this treatment method.
In a letter to the FDA ahead of the meeting, the Alzheimer’s Association said publicly available data to date “justifies approval accompanied by a phase 4 post-marketing surveillance study.”
“The alternative, which requires completion of an additional phase 3 trial, will deny broad access for up to four years while it’s completed. The four-year delay is too long to wait for millions of Americans. Faced with a progressive, fatal disease Four- The organization says the one-year delay is too long for millions of Americans to wait.
A final FDA decision on Biogen is scheduled for March.
This is a development story. Please check back for updates.