The Alzheimer’s medication Aduhelm is being discontinued by drugmaker Biogen as it shifts resources to its other Alzheimer’s medication, Leqembi, and developing other treatments, the company said in a statement Wednesday.
“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. We plan to further advance the launch of Leqembi, together with Eisai, and continue to bolster innovation with the development of the other assets in our pipeline,” Biogen CEO and President Christopher Viehbacher said in a statement.
The company said it will end the study that would’ve been needed for full approval from the US Food and Drug Administration. The decision to end development of the drug, which received accelerated approval in 2021, was “not related to any safety or efficacy concerns,” it said.
The drug has had a complicated regulatory history. The company had almost abandoned its clinical trials in March 2019 after an independent committee found that the drug probably would not slow the cognitive and functional impairment — the decline in memory, language and judgment — that comes with Alzheimer’s. Another trial showed some benefit.
But the FDA and Biogen started a “working group” in June that year to see whether the effort to get the drug to market could be saved. The FDA ultimately gave it a green light through the accelerated approval process, which allowed the agency to approve a drug on a single study and additional evidence when there is an unmet need.
For Aduhelm, FDA made the decision without going back to its advisory committee, and it approved the drug for all patients, even though the company’s studies were only in those early in their disease.
In 2022, the US House Committee on Oversight and Reform and the Committee on Energy and Commerce investigation said in a highly critical report that the effort between Biogen and the FDA to get the high-priced drug approved was “rife with irregularities” and “exceeded the norm in some respects.”
The report concluded that Biogen set an “unjustifiably high price” for the drug to “make history” for the company, which saw the drug as an “unprecedented financial opportunity.” The company had priced the drug at $56,000 per year, even though its actual impact on the broad patient population was unknown.
Medicare went on to restrict coverage of Aduhelm to those enrolled in qualifying clinical trials, saying at the time that the “significant of serious unknown factors could result in harm.”
In a statement Wednesday, the Alzheimer’s Association recognized the impact Aduhelm had on the Alzheimer’s landscape, saying its accelerated approval kicked off “a new era” of treatments for the disease and “provided hope for the millions of people living with early Alzheimer’s, and their families.”
Dr. Allan Levey, director of the Goizueta Alzheimer’s Disease Research Center at Emory University, said he didn’t think the announcement would affect too many patients. Most doctors prescribe Leqembi, which is covered by Medicare, unlike Aduhelm, he said.
“People are getting that, and it works in a similar way, but unlike with Aduhelm, there has been far less controversy,” Levey said.
Dr. Heather M. Snyder, the Alzheimer’s Association vice president of medical and scientific relations, said some people have been taking Aduhelm, and some have been enrolled in trials.
“For anybody that is receiving this news today as participants in the trials, as well as individuals that are taking this medication or just finding out about this announcement today, the Alzheimer’s Association recommends that those individuals reach out, whether it be to the clinical trial study contact or to their personal health care provider, to talk through how this announcement changes their treatment and their care plan going forward,” Snyder said.
Alzheimer’s disease is the most common form of dementia, which is a general term for the loss of memory and intellectual abilities. The US Centers for Disease Control and Prevention estimates that about 6 million people are living with the disease, and unless there is a significant medical breakthrough, that number is expected to grow to 13.8 million by 2060, according to the Alzheimer’s Association. Alzheimer’s disease is fatal, and there is no cure. It is a slow-moving disease that starts with memory loss and ends with severe brain damage.
There is some reason for hope in the field, Snyder said. There’s another medication under FDA review, donanemab, and a decision from the FDA is expected this year. And, Snyder said, there is an “incredibly robust pipeline of what’s being developed and in clinical trials.”
“I’m incredibly optimistic about the future of treatments in this space,” Snyder said. “We see in the bigger landscape just a continual increase in what’s moving into the clinical trials pipeline, a diversity of what’s being targeted with the biology, and incredible momentum in lifestyle and behavioral interventions that are being tested and evaluated as potential treatments for prevention or risk reduction.
“All of that is moving forward just in an accelerated pace, and we’re so grateful to the participants in all of these studies for moving the science forward.”
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