Eli Lilly is now planning to apply for an accelerated FDA approval for its Alzheimer’s treatment, donanemab, this year.
Lilly has made the announcement just weeks after the FDA rendered its fateful decision on Biogen’s aducanumab, an amyloid-targeting drug that has been criticized for not being effective enough for approval.
In January, Lilly reported positive preliminary results from a mid-stage trial of donanemab, an antibody treatment that also targets amyloid plaques in the brain. Results from the phase 2 study, called TRAILBLAZER-ALZ, showed that the drug reduced the rate of decline by 32%, compared to placebo, on a clinical Alzheimer’s scale.
Lilly is also conducting a phase 3 trial of the drug. But with the FDA’s potential bar for approval set by the Biogen OK, Lilly isn’t waiting for the results of its late-stage trial and said it will file for approval based on the results of TRAILBLAZER-ALZ.
News of the upcoming Lilly filing sent the company’s shares up by 8% before trading began.
