Eli Lilly said Oct. 26 it has begun submitting data to the FDA for accelerated approval of donanemab, its experimental drug to treat Alzheimer's.
The Indianapolis-based drugmaker began filing a rolling submission of its clinical trial data and expects to complete the application in the next several months, The Wall Street Journal reported. That means an FDA decision could come in the second half of 2022.
Eli Lilly previously didn't expect to file for authorization of the drug until 2023 because the company thought it would need more data from its ongoing study, for which results are expected in 2023. But the drugmaker's plans changed when the FDA approved Biogen's new Alzheimer's drug, Aduhelm, in June using the accelerated approval pathway, according to the Journal. Aduhelm was the first FDA approval for an Alzheimer's treatment since 2003 and the first ever designed to slow the disease's progression rather than alleviate symptoms.
Eli Lilly said in June after Biogen's Aduhelm approval that it planned to file for approval of its drug this year.
Eli Lilly said it will conduct a phase 3 trial comparing its drug donanemab to Aduhelm to see which is better at clearing amyloid plaque in the brain in early stage Alzheimer's patients. The drugmaker plans to begin trial enrollment this year, and results of the study could be released late next year.
Both Eli Lilly and Biogen's drugs are designed to clear amyloid plaque from the brain, which scientists suspect is a primary cause of the loss of cognitive function seen in Alzheimer's patients.
Eli Lilly's donanemab is an intravenous infusion. A phase 2 study of 257 patients showed it slowed the progression of Alzheimer's disease by 32 percent over 18 months, according to results published in March.
Read Eli Lilly's full news release here.