Biogen Inc. 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 that afflicts 6 million Americans.
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.
The FDA announced the decision in a statement on Monday.
“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 agency said.
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 Cambridge, Massachusetts-based 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.
Now, it’s on the cusp of rolling out a product widely expected to be a blockbuster, even amid questions about the health-care system’s capacity to cope with demand.
Biogen shares were halted ahead of the news in New York trading and hadn’t yet resumed as of 11:26 a.m. in New York. U.S.-traded shares of Eisai leapt 42% to $105.21.
“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.