FDA Approves Second Alzheimer’s Drug That Can Modestly Slow Disease

— U.S. officials have approved another Alzheimer’s drug that can modestly slow the disease, providing a new option for patients in the early stages of the incurable, memory-destroying ailment.

The new drug's approval was expected after an outside panel of FDA advisors unanimously voted in favor of its benefits at a public meeting last month. That endorsement came despite several questions from FDA reviewers about how Lilly studied the drug, including allowing patients to discontinue treatment after their plaque reached very low levels.

The FDA approved Kisunla, known chemically as donanemab, based on results from an 18-month study in which patients given getting the treatment declined about 22% more slowly in terms of memory and cognitive ability than those who received a dummy infusion. “Certainly getting an infusion once a month is more appealing than getting it every two weeks,” Schindler said.Lilly's drug has another potential advantage: Patients can stop taking it if they respond well.

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