Employed at Biogen in Cambridge, Mass.
Suzanne Kreiter | The Boston Globe | Getty Images
Biogen stock rose 42% Wednesday morning after Food and Drug Administration officials said they had enough data to support approval of the company's experimental Alzheimer's drug aducanumab.
The FDA agrees that the late-stage Biogen Study 302 results are "very convincing" and that the study "may be the major contributor to providing substantive evidence of aducanumab's effectiveness".
"Based on the above considerations, the applicant has provided substantial evidence of effectiveness in support of the approval," the FDA staff said in a review document published on the agency's website.
The FDA also said the drug "has an acceptable safety profile that would support use in people with Alzheimer's disease".
The drug from the Cambridge, Massachusetts-based company targets a "sticky" compound in the brain known as beta-amyloid, believed to be involved in the devastating disease.
A group of outside experts is expected to meet on Friday to recommend FDA approval of the drug.
Alzheimer's disease is a progressive neurodegenerative disorder that slowly destroys memory and the ability to think. The Alzheimer's Association estimates that 5.8 million Americans are living with the disease.
There are currently no FDA-approved drugs that can reverse the mental decline of Alzheimer's, the sixth leading cause of death in the United States.
The FDA has approved Alzheimer's drugs that are designed to relieve symptoms without reversing or slowing the disease on its own. Biogen estimates that around 1.5 million people with early-stage Alzheimer's disease in the United States could be candidates for the drug, according to Reuters.
Analysts were previously skeptical of the drug's benefits after Biogen reversed its decision to seek regulatory approval.
In March 2019, Biogen pulled the plug on the Alzheimer's drug after an analysis by an independent group found the drug is unlikely to work. However, the company shocked investors in October of that year when it announced it was finally filing for 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 Alzheimer's disease."
The FDA's final decision on Biogen's drug is expected by March.