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Lilly slows FDA submission of Alzheimer’s drug after Medicare decision

February 3, 2022

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Lilly’s announcement is a consequence of Medicare’s draft policy, which, if finalized later this year, would restrict coverage for Aduhelm and donanemab to people enrolled in randomized, placebo-controlled trials.

Both drugs work by targeting deposits of a sticky protein, called amyloid beta, in the brain. Amyloid buildup has long been believed to cause Alzheimer’s, although nearly every trial of an amyloid-targeting drug has failed to slow disease progression. One of the main trials testing Aduhelm, for instance, showed no benefit to the drug, a result that’s fueled debate over how well the drug actually works.

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