Finally, a Drug for Alzheimer's?
Bloomberg Businessweek|May 17, 2021
After scores of failed drugs, the FDA is set to rule on a controversial candidate
By Robert Langreth, with John Tozzi and Riley Griffin

Jeffrey Borghoffwas just 51 when he received a diagnosis of early-stage Alzheimer’s disease. Shortly thereafter, he retired from his job as a software developer and went on disability. He also quickly enrolled in a trial for an experimental Biogen Inc. drug to remove an aberrant amyloid protein from his brain that researchers believe is tied to a reduction in memory and brain function in Alzheimer’s patients. Since then, with the exception of a brief interruption, he’s been getting monthly infusions of the medicine, named aducanumab, which he credits with slowing his cognitive decline. Now 57, Borghoff can’t drive because he confuses red and green lights, but he can still cook and take walks with his wife, Kimberly, and their dog. His life, he says, is full.

Now Borghoffis steeling himself: The U.S. Food and Drug Administration is set to rule soon on aducanumab, which has already been rejected by an FDA advisory panel of medical experts. The FDA may also reject the drug, requiring years of additional study. That could eventually force him to search for a trial of a different treatment—something that takes time that many patients simply don’t have.

“We’re fighting like hell to get this drug approved,” says Borghoff, of Forked River, N.J., who also spoke to FDA regulators in favor of the Biogen medicine at a meeting of patients in January. “Every day they are making progress in cancer and diabetes and other diseases. We need something for Alzheimer’s disease,” he says.

The decision, which Biogen says the FDA will make by June 7, is one of the most consequential the agency has faced in years and is guaranteed to be controversial no matter what the outcome. Existing Alzheimer’s drugs only temporarily improve symptoms. If approved, aducanumab could become the first drug ever authorized to slow the course of the most common type of dementia. That suggests the drug could become a hit, providing at least some hope to an estimated 6 million Alzheimer’s sufferers in the U.S.—and likely billions of dollars in annual sales for its makers.

That Biogen’s drug is even up for approval at all is noteworthy. In early 2019, Biogen and its Tokyo-based partner Eisai Co. discontinued two big trials, citing a lack of evidence to merit further study. The drug appeared destined to take its place among the hundreds of Alzheimer’s failures over several decades. But Biogen and Eisai, in a surprise move, later reversed course and submitted the drug for approval. “This [FDA review] is a momentous decision of tremendous consequence,” says Marwan Sabbagh, director of translational research at the Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas and a consultant to Biogen on Alzheimer’s treatments, who thinks the benefit from the drug is meaningful.

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