Eli Lilly isn’t waiting for results from a phase 3 trial of its Alzheimer’s drug before it files for an FDA approval.
According to the company, it’s prepping to submit an application for donanemab, a monoclonal antibody, by the end of the year using data from a phase 2 trial. The company’s phase 3 study isn’t slated for completion until 2023.
Like Aduhelm — Biogen’s Alzheimer’s treatment that was approved by the FDA in June — donanemab was developed to clear amyloid plaques from the brain. Although scientists continue to dispute the idea that clearing amyloid improves Alzheimer’s symptoms, Lilly said that if the approach to winning an FDA approval worked for Biogen, it could work for them.
Lilly reported positive results from its phase 2 trial in January and said that so far, its treatment is more effective at clearing amyloid than other drugs — a point that the company said could make it a more attractive option to prescribers than Aduhelm.
"If you believe that lowering amyloid plaque is a good thing to do, you're going to want the drug that lowers amyloid plaque the most," Chief Scientific Officer Daniel Skovronsky said on a recent investor call.
