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Eli Lilly announced Thursday that it had received the FDA’s Breakthrough Therapy designation for donanemab, an investigational antibody therapy for Alzheimer’s disease. The announcement follows a Phase 2 clinical trial that studied the safety and effectiveness of the drug in patients with early, symptomatic Alzheimer’s disease.
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Eli Lilly said in a news release Thursday that it plans to submit the drug for FDA Accelerated Approval later this year. The drug targets a beta-amyloid protein in the brain, and is currently being assessed in an ongoing Phase 3 clinical trial dubbed TRAILBLAZER-ALZ 2.
Breakthrough Therapy designation aims to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinical significant endpoint.
FDA APPROVES BIOGEN'S ALZHEIMER'S DRUG
The FDA’s decision comes several weeks after the agency granted Biogen’s Alzheimer’s drug accelerated approval, which prompted several advisory panel members to resign. Aduhelm became the first Alzheimer’s drug to receive approval in nearly two decades, but received mixed reviews. In November, the Peripheral and Central Nervous System Drugs Advisory Committee said that it was not reasonable to consider clinical benefit of the drug based on one successful study.
THIRD MEMBER OF FDA ADVISORY PANEL RESIGNS OVER ALZHEIMER'S DRUG APPROVAL
Dr. Patrizia Cavazzoni, the FDA’s Center for Drug Evaluation and Research director said that when the panel issued their opinion, it had not discussed the option of Accelerated Approval, which allows for drugs targeted at serious conditions that fill an unmet medical need to be approved "based on a surrogate endpoint."
The panelists have since countered that they were not asked to consider that possibility as the committee had determined they would not use the amyloid "as a surrogate for efficacy."
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Last week, the first patients outside of clinical trials received the drug.
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