FDA approves controversial Alzheimer's therapy despite mixed evidence

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The FDA has approved the first new treatment for Alzheimer’s disease in nearly two decades — bucking the advice of its own expert advisory panel, which last fall said there was not enough evidence to prove the drug works

Roughly 5.8 million Americans have the disease, which is progressive and ultimately fatal. | Eric Risberg, File/AP Photo.

"I'm quite disappointed in the decision by the FDA. It's not in the best interest of patients and not in the best interest of our health care system," said Joseph Ross, a physician at Yale University and co-director of the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation. "This historic moment is the culmination of more than a decade of groundbreaking research in the complex field of Alzheimer’s disease," Michel Vounatsos, Biogen's chief executive officer, said in a statement. "We believe this first-in-class medicine will transform the treatment of people living with Alzheimer’s disease and spark continuous innovation in the years to come."

In her statement, Cavazzoni said that while pre-approval clinical trials split on whether the drug reduced symptoms of Alzheimer's disease, all of those studies showed the drug "consistently and very convincingly reduce the level of amlyoid plaques in the brain in a dose- and time-dependent fashion."

 

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