Eli Lilly

A big talking point of 2023 was the use of monoclonal antibodies against Alzheimer’s disease. Biogen and Eisai’s aducanumab failed to generate excitement, but lecanemab is a different story. There are still concerns about how successful it will prove to be, but it has certainly shown that new advancements in drug development for Alzheimer’s are possible.

Enter Eli Lilly with its own anti-amyloid monoclonal – donanemab – that has been garnering significant attention since positive phase III results in 2023, with many believing that it could be even more effective than lecanemab. A statement from Eli Lilly in 2023 said, “This is the first Phase 3 trial of any investigational medicine for Alzheimer’s disease to deliver 35 percent slowing of clinical and functional decline.”

Unfortunately, the company was in the headlines again when its bid for accelerated approval from the FDA was rejected in January 2023 because of the limited number of patients with at least 12 months drug exposure. Lilly has since filed a new submission with the FDA – and a decision is expected later in 2024.

The year 2023 was actually a somewhat tough one for Lilly, which also received two other rejections from the FDA – although these were for deficiencies at a third-party contract manufacturer rather than issues with the drug itself.

Full year revenue for 2023 was not available at the time of publication, but the company reported 2023 Q4 revenues as rising by 28 percent compared with the same quarter the previous year.