Biogen Alzheimer’s drug approved in disease landmark
Cambridge-based Biogen received approval for its controversial Alzheimer’s disease therapy, a landmark decision that stands to dramatically change treatment for the debilitating brain condition.
After decades of research failures by numerous companies, Biogen’s aducanumab became the first drug cleared by the U.S. Food and Drug Administration to slow the course of the mind-wasting disease.
The antibody therapy, which will be sold under the brand name Aduhelm, works by removing amyloid, a harmful protein that clogs the brains of Alzheimer’s patients. The last new drug treatment for the disease was first approved in 2003; existing therapies help with symptoms but don’t alleviate the underlying damage.
“In determining that the application met the requirements for accelerated approval, the agency concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy,” the FDA said Monday.
The approval is one of the most consequential FDA decisions in recent years, and welcome news for millions of Americans with Alzheimer’s disease and their families. Patient advocacy groups have supported the drug’s clearance despite skepticism from some scientists about its mixed record in clinical trials.
The approval is also a significant victory for Biogen and its Tokyo-based partner Eisai Co. Biogen has seen wild swings in its share price with nearly every twist and turn of aducanumab’s development. Biogen shares gained 40% on the news Monday.
“This historic moment is the culmination of more than a decade of groundbreaking research in the complex field of Alzheimer’s disease,” said Biogen Chief Executive Officer Michel Vounatsos in an emailed statement.
The long-awaited verdict is certain to be scrutinized. Scientists are still furiously debating amyloid’s role in the disease.
In one giant trial conducted by Biogen, the drug was ineffective overall. A second, similar study found that high doses of the drug slowed progression of the disease by 22% over 18 months.
The FDA approved the drug under its accelerated approval program, which means the companies will need to conduct further studies, and the agency could in theory remove it from the market if those studies don’t show a benefit.
from Boston Herald https://ift.tt/2TDE2bx
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