Eli Lilly Delays Application for Experimental Alzheimer’s Drug
Eli Lilly said it will hold off on seeking accelerated approval of its investigational Alzheimer’s drug, donanemab, until later this year, rather than completing filing during the first quarter as originally intended.
The move follows a recent Centers for Medicaid and Medicare Services (CMS) draft decision restricting coverage of Alzheimer’s antibody therapies only to participating in clinical trials. A final CMS decision is due in April.
The company wants to shift focus away from when exactly it will seek accelerated approval since the commercial impact is likely to be limited, said Daniel Skovronsky, Lilly’s chief scientific officer in a Feb. 3 investor call.
Medicare had announced a proposal to limit coverage for monoclonal antibodies targeting amyloid to treat Alzheimer’s disease.
Lilly anticipates data from a confirmatory donanemab in 2023.
According to recent research from Spherix Global Insights, about half of neurologists are skeptical about prescribing monoclonal antibodies targeting amyloid, given the controversy related to Biogen’s aducanumab.
A study published in NEJM in 2021 found that patients with early Alzheimer’s disease who received donanemab had an improved composite score for cognition at 76 weeks compared to placebo.
February 7, 2022
