The FDA plans to convene an advisory committee meeting to discuss the safety profile and efficacy of Eli Lilly’s Alzheimer’s candidate, the company announced Friday.
The FDA will convene its Peripheral and Central Nervous System Drugs Advisory Committee to discuss Eli Lilly’s application for its Alzheimer’s disease antibody donanemab, the company announced Friday.
In this deep dive, BioSpace examines what’s next for Leqembi, the true cost of anti-amyloid antibodies, and what other Alzheimer’s treatments are coming down the pipeline.
Following the full approval of Leqembi, the CMS suggests expanding its coverage of beta-amyloid PET scans, which could improve the uptake of novel Alzheimer’s disease treatments.
The company said it will file a marketing application later this year for the drug under the FDA’s accelerated approval pathway.