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FDA to review controversial Alzheimer’s drug from Cambridge-based Biogen
"We have never before been this close to approval of a medication for Alzheimer’s that could change the progression of the disease, not just the symptoms.”
The Food and Drug Administration is expected to make a historic decision by June 7: whether to approve a treatment for mild cognitive decline and early-stage dementia caused by Alzheimer’s.
The FDA hasn’t approved an Alzheimer’s drug since 2003, and there are still no approved treatments that target the cause, only that help manage the symptoms. This would be the first approved drug to target the brain function deterioration caused by the disease.
The treatment, produced by Cambridge-based Biogen and Tokyo’s Eisai Co., is called aducanumab and works by binding to the plaques between neurons and causing an immune response that removes them.
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The drug’s development has been marked by strong opinions for and against its approval. At the heart of it all is Biogen, and whether the company conducted comprehensive studies and collected enough data to support the drug’s approval and mass deployment.
A Washington Post article put it simply: The trials show the drug eliminates the plaque, but there is still debate as to whether that actually improves cognitive ability.
Conflicting opinions on approval
Biogen halted two clinical trials for the treatment in March 2019 after an interim analysis showed they would not achieve the stated goals. Then, in October 2019, Biogen resurrected the studies after reviewing data that had not been included in the original study. A press release noted that one of the studies had originally shown a significant reduction in clinical cognitive decline, and the new data showed that patients in the other study who got a high enough dose of the drug experienced similar improvement.
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In a December 2019 opinion piece for STAT, Dr. Jason Karlawish, a neurology and medical ethics professor at the University of Pennsylvania, wrote of his excitement about aducanumab.
“Biogen’s reinterpretation of its data must still be subjected to FDA and peer review, of course,” he wrote. “But if it holds up, I believe that aducanumab will be a shot heard round the world: the beginning of the end of Alzheimer’s disease.”
Just yesterday, in another piece for STAT, Karlawish shared that he would not prescribe the drug if it were approved.
“[I]f it gets the green light, I can’t see myself recommending it to my patients,” he wrote. “Colleagues of mine in the Alzheimer’s sphere are also reluctant about approving aducanumab. Why? Biogen hasn’t made a convincing case for it.”
Karlawish’s hesitancy stems from the “murky” data collection. He wants to see a third study before FDA approval.
“Aducanumab is not the drug to launch a new era of Alzheimer’s treatment,” he wrote. “It hasn’t been properly studied, and so the FDA has incomplete data to form a judgment. The cause of this is a series of decisions that were good for business but bad for science and patient care.”
A big impact, either way
Over 6.2 million Americans live with Alzheimer’s, a number that is expected to more than double by 2050, and Karlawish also pointed out the burden this would put on Medicare if approved. A review from the Boston-based Institute for Clinical and Economic Review found that treatment could cost up to $50,000 annually.
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The drug is staunchly supported by the Alzheimer’s Association, which submitted a letter to the FDA asking for the aducanumab’s approval.
“This is an exciting moment for millions of Americans and their loved ones who have waited decades for a new, more effective treatment for Alzheimer’s disease to be available,” reads a statement on their website. “Whatever the final decision by the FDA, this is an important moment. We have never before been this close to approval of a medication for Alzheimer’s that could change the progression of the disease, not just the symptoms.”
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