Lilly's Alzheimer's drug donanemab gets June adcomm after delay

Eli Lilly is scheduled to face an evaluation by a panel of Alzheimer’s specialists on June 10, which will be crucial for the approval decision of its drug, donanemab, following a surprising delay by the FDA in early March. According to a company statement released on Tuesday, donanemab will be reviewed by the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee.

Lilly has indicated that the FDA has shown particular interest in several aspects of donanemab. One primary area of focus is the safety profile of the drug. Additionally, the FDA is examining Lilly's proposal to discontinue treatment once the drug successfully eliminates amyloid plaques in the brain. Another significant point of interest is the analyses that propose the levels of the brain protein tau could serve as a predictor of how well a patient may respond to the treatment.

This upcoming review by the advisory committee is a critical step for Eli Lilly as it seeks approval for donanemab. The company has been working to address the FDA's concerns and provide comprehensive data that highlights the drug's efficacy and safety. The outcome of this meeting will determine the next steps in the regulatory process for donanemab and its potential availability to patients suffering from Alzheimer’s disease.