Alzheimer’s drug that slowed cognitive decline gets FDA approval as doctors debate its safety and effectiveness
“This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease,” Billy Dunn, director of the FDA’s Office of Neuroscience, said in a statement. He said the agency anticipates receiving the data from the later trial soon.regarding its 2021 accelerated approval of another Alzheimer’s drug, called Aduhelm, that had been panned by the agency’s outside experts.
“I would tell a patient, ‘In my opinion, the risks exceed the benefits, and it is not clear that it will markedly change your course,’ ” said Kenneth Covinsky, a geriatrician at the University of California at San Francisco.“If I were at FDA I would ask for longer studies” to delve deeper into safety concerns and effectiveness, said Matthew Schrag, a neurologist at Vanderbilt University Medical Center.was based on a biomarker — amyloid removal — that is thought to help patients.
“I think it would be reasonable for one patient to say, ‘This is a risk I am willing to take,’ and another to say, ‘I’m not willing to take this risk because I don’t think the benefit will be big enough,’ ” she said.Tony Gonzales, 48, a former radio personality who lives in Santa Maria, Calif., is eager to try the drug.
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