Staff at Biogen in Cambridge, Mass.
Suzanne Kreiter | The Boston Globe | beautiful images
Biogen shares rose 42% in mid-morning trading Wednesday after Food and Drug Administration staff said they had enough data to support the company’s trial Aducanumab drug approval. .
The FDA says it agrees that the results from the Biogen end-stage trial, study 302, are “highly convincing”; and that this study “is likely to contribute mainly to demonstrating significant evidence of the effectiveness of aducanumab. “
“Based on the above considerations, the applicant provided substantial evidence of effectiveness to support approval,” said the FDA staff in a drug review document published on the institution’s website. concerned.
The FDA also says the drug has an “accepted safety profile that may support use in people with Alzheimer’s disease.”
The company’s Cambridge, Massachusetts-based drug targets a “sticky” compound in the brain called beta-amyloid, which is believed to play a role in the malignancy.
A panel of outside experts is scheduled to meet on Friday to ask the FDA to approve the drug.
Alzheimer’s disease is a progressive neurodegenerative disorder that slowly destroys memory and thinking skills. The Alzheimer’s Association estimates 5.8 million Americans are living with the disease.
There are currently no FDA-approved drugs that can reverse the mental decline caused by Alzheimer’s disease, the sixth leading cause of death in the United States.
The FDA has approved Alzheimer’s drugs that are intended to help the symptoms, not actually reverse themselves or slow the disease. Biogen estimates that about 1.5 million people with early Alzheimer’s disease in the United States could be candidates for the drug, according to Reuters.
Analysts have previously questioned the benefits of the drug after Biogen rejected the decision to seek regulatory approval.
In March 2019, Biogen withdrew from relationship for an Alzheimer’s drug after analysis from an independent group showed that the drug was not likely to work. However, the company shocked investors in October of that year when it announced that it was seeking regulatory approval for the drug.
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-stage Alzheimer’s disease.”
A final FDA decision on Biogen is scheduled for March.