The regulator wants to see clinical data from at least 100 patients who have taken donanemab for a year
Eli Lilly & Co. LLY now plans to seek full approval of its experimental Alzheimer’s disease treatment after the Food and Drug Administration refused to grant a speedier approval using less rigorous clinical data.
Why... Eli Lilly & Co. LLY now plans to seek full approval of its experimental Alzheimer’s disease treatment after the Food and Drug Administration refused to grant a speedier approval using less rigorous clinical data. “Patients and physicians will be well served by having the full Phase 3 data available alongside our Phase 2 data when they need to make treatment decisions,” Anne White, president of Lilly Neuroscience, said in a statement.This is a special type of regulatory approval that allows the FDA to more quickly OK drugs that treat serious, unmet conditions or demonstrate an obvious, meaningful benefit over existing therapies.
That rule limited access to Eisai 4523 and Biogen’s BIIB Aduhelm, an Alzheimer’s treatment with a controversial back story and unclear clinical benefit that received accelerated approval in 2021.Eisai and Biogen just received accelerated approval for Leqembi, another Alzheimer’s drug that will compete with donanemab if and when that drug is approved.
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