Eli Lilly plans to file for accelerated approval of its Alzheimer's drug this year

Eli Lilly said June 24 it plans to file for approval of its Alzheimer's drug donanemab this year under an accelerated pathway after the FDA granted it breakthrough therapy designation. 

Donanemab is an antibody drug that targets a modified form of beta amyloid, the same type of toxic protein that Biogen's Alzheimer's drug Aduhelm targets. Beta amyloid are believed to destroy the brain. 

Eli Lilly is conducting phase 3 studies of the drug in patients with early Alzheimer's. The drugmaker said in March that a clinical trial of 257 people showed the drug slowed the progression of the disease by 32 percent over 18 months. It also completely removed beta amyloid from the brains of 68 percent of the trial participants after 18 months. 

After the news that Eli LIlly plans to file for approval this year, its shares rose more than 8 percent, and Biogen's fell 5 percent, according to Bloomberg. Paul Matteis, an analyst at Stifel Financial Corp, told Bloomberg that the drugmaker's move to seek accelerated approval this year "is somewhat surprising to us from a timing perspective." 

But, donanemab's efficacy data looks good compared to Aduhelm's and is "less confusing," Mr. Matteis added. He also said that if Eli Lilly's drug is approved, it could drive down the price of Aduhelm. 

Aduhelm was approved June 7, and the price was set at $56,000 per year.

Copyright © 2022 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars