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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FDA rejects Eli Lilly's proposed Alzheimer's treatment, says more data neededThe setback could delay a potential commercial introduction of the highly anticipated drug by at least several months, if the Food and Drug Administration...
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Eli Lilly says U.S. FDA rejects accelerated approval for Alzheimer's drugEli Lilly and Co on Thursday said the U.S. Food and Drug Administration had rejected accelerated approval of its experimental Alzheimer's drug because it had not submitted enough trial data from patients who were treated for at least a year.
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Eli Lilly says U.S. FDA rejects accelerated approval for Alzheimer's drug(Reuters) -Eli Lilly and Co on Thursday said the U.S. Food and Drug Administration had rejected accelerated approval of its experimental Alzheimer's drug because it had not submitted enough trial data from patients who were treated for at least a year. Lilly said the FDA had sent it a complete response letter for donanemab, an antibody designed to remove amyloid protein plaques from the brains of people with early Alzheimer's. Such letters typically outline concerns and conditions that must be addressed to gain U.S. approval. The FDA had issued the letter 'due to the limited number of patients with at least 12 months of drug exposure data provided in the submission,' Eli Lilly said.
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Eli Lilly announces details on plans for development in Lebanon's LEAP DistrictThe development of the campus will encompass just over 1.6 million square feet, including two three-story 330,000-square-foot peptide manufacturing facilities.
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