The verdict is in: The FDA has approved Biogen’s controversial Alzheimer’s treatment aducanumab.
The FDA’s approval on Monday is set to cause a ripple effect among drugmakers and researchers studying the elusive disease, the sixth leading cause of death in the U.S., and comes after months of intense controversy over whether Biogen’s Alzheimer’s treatment actually helped with cognitive decline.
For Biogen, the company's all-in bet on aducanumab, now marketed as Aduhelm, comes amid serious troubles elsewhere in its business. Multiple sclerosis drug Tecfidera and spinal muscular atrophy med Spinraza have been facing increasing competitive pressures, leading the company to post a sales decline in 2020.
Aducanumab is a monoclonal antibody designed to break down amyloid plaque buildup that is thought to worsen Alzheimer’s disease. The drug is the first to treat the course of the disease, not just its symptoms, and the first Alzheimer's medicine approval in nearly two decades—and among the few drugs of any kind approved after a stark rejection from the FDA's own advisory panel of experts.
It's a sure win for patients and advocacy groups lobbying for the green light, as well as Biogen and its Japanese pharma partner Eisai, who have urged the drug agency to approve the treatment, arguing that there are no other options to treat the memory-degenerating disease that afflicts more than 6 million people in the U.S.
On the other hand, it’s a stark rebuke against the physicians and the FDA’s own panel of independent advisors who have been sharply critical of the once-failed drug. That group has contended that Biogen’s treatment hasn’t proven effective enough to earn the agency’s coveted approval.
The FDA awarded aducanumab an accelerated approval, which grants an earlier green light to drugs that treat serious conditions and fulfill an unmet medical need.
In its decision on Monday, the FDA said aducanumab “consistently and very convincingly reduced the level of amyloid plaques in the brain” in both studies. A reduction in those plaques is “reasonably likely to predict important benefits to patients,” the agency argued.
Its accelerated approval comes with stipulations. Biogen will have to conduct post-approval studies to verify the treatment’s anticipated clinical benefit. If those trials, known as phase 4 studies, don’t verify aducanumab’s worth, the agency said it could remove it from the market entirely.
Known for solutions that yield results, Seth Yakatan has completed or advised on acquisitions and corporate finance transactions totaling over $3 billion. He is CEO of Katan Associates International—a financial strategy and merchant banking firm specializing in commercialization and asset monetization—especially those within life-science and e-commerce sectors.