An experimental Alzheimer’s drug moderately slowed the effects of the disease but was linked to patient safety risks that warrant longer clinical trials, according to a study published late Tuesday.
That drug, known by the brand name Aduhelm, was approved by the FDA last year despite conflicting data on its effectiveness. Aduhelm“This is an unambiguously positive clinical trial,” said Gil Rabinovici, a neurologist at the University of California at San Francisco, while acknowledging that there is a “potentially serious safety concern that will require a discussion with patients.
“I worry any minor benefit may be washed out by the practical difficulties of living with the drug and the substantial risks associated with taking the drug,” he said in an interview. Eisai and Biogen reported that patients in the trial experienced brain swelling and bleeding, which are known to be complications of anti-amyloid drugs, but the companies said the rates were within expectations. Concerns about the drug’s safety, however, were heightened by the two patient deaths.
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