![]() ![]() ![]() Leqembi is currently undergoing the FDA's standard review process, with a decision due by July 6. approval of two similar medicines developed by partners Eisai and Biogen - Leqembi as well as Aduhelm, which failed to gain traction with doctors or insurers after showing little evidence that it slowed cognitive decline.īoth were approved under the FDA's accelerated review program, based on their ability to remove amyloid plaques. Lilly's drug is poised to become the third in its class on the market following U.S. It also said 47% of donanemab patients in the 18-month trial had no disease progression at 12 months, compared with 29% of the placebo group. At 12 months, half had no evidence of amyloid plaques, the company said. Study participants received a monthly intravenous infusion of donanemab. Those results are set to be presented at an Alzheimer's meeting in Amsterdam this summer. approval decision should come by year-end or early 2024.Īlzheimer's experts said they were eager to see full results of the study, including data on how the drug performs in people who carry an Alzheimer's risk gene known as APOE4, who have been prone to increased risk of side effects in prior trials. approval by the end of June, and with regulators from other countries shortly thereafter. ![]() ![]() Lilly said it plans to file for traditional U.S. Eric Reiman, executive director of the Banner Alzheimer's Institute, which is running a study of donanemab in presymptomatic patients. "Clearly, one saw benefits here, but there is some risk that needs to be considered," said Dr. Lilly said the incidence of serious brain swelling in the donanemab study was 1.6%, including two deaths attributed to the condition, and a third, after an incident of serious brain swelling.Ī research note by SVB Securities analyst David Risinger was headlined: "Donanemab Succeeds, But Safety Remains a Concern". ![]()
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