Biogen said it is discontinuing its controversial drug Aduhelm, so it can focus resources on other Alzheimer’s treatments that drive long-term growth.
This includes shifting its priorities to its blockbuster drug Leqembi, which was developed with Japan’s Eisai and approved in 2023.
“As a pioneer in Alzheimer’s disease, Biogen is reprioritizing resources to build a leading franchise to address the multiple pathologies of the disease and patient needs,” Biogen CEO Christopher Viehbacher said.
While the company is discontinuing the development of Aduhelm, the drug “paved the way for a new class of drugs and reinvigorated investments in the field,” Viehbacher added.
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To date, more than 6 million Americans are living with Alzheimer’s, according to the Alzheimer’s Association. That number is expected to surge to nearly 13 million by 2050.
Aduhelm was greenlighted by the Food and Drug Administration (FDA) for the treatment of Alzheimer’s in 2021. At the time, the FDA – which granted accelerated approval – said the drug represented a “first-of-its-kind treatment.” It had been the first new treatment approved for the progressive disease since 2003.
The FDA told FOX Business that Biogen was required to conduct a post-approval clinical trial to verify clinical benefit. That study will now be stopped since the company is voluntarily withdrawing the drug.
The move to discontinue the drug and terminate the trial was not related to any safety or efficacy concerns, the company noted.
However, the medical community was concerned that the risks of Aduhelm outweighed its benefits, according to New York City-based emergency room physician Dr. Robert Glatter.
Glatter told FOX Business that the drug was known to cause both brain swelling and brain bleeding. Medicare acknowledged this and “decided to significantly limit coverage of the drug so that it would only be accessible to patients enrolled in clinical trials,” Glatter continued.
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While Medicare does cover other Alzheimer’s drugs that have full approval, “Adulhelm was never included in such coverage due to the aforementioned concerns,” Glatter said.
Leqembi made headlines in July when it became the first anti-amyloid beta treatment with traditional approval from the FDA in the United States. Its approval for the U.S. market marked a major milestone in the treatment of the progressive disease.
Dr. Sharon Cohen, a behavioral neurologist and clinical trial investigator for the Clarity AD study, previously told FOX Business that this was the first time the FDA has approved a drug that has been shown to “slow down the clinical aspects of Alzheimer’s disease, meaning people will lose memory at a slower rate and lose their functional abilities at a slower rate.”
Cohen said that there are drugs that have been able to clear amyloid plaque that forms in the brain, which is the sticky protein that is very damaging in Alzheimer’s disease.
