Lilly Waiting On Phase III Data For Donanemab

Lilly no longer plans to complete an accelerated approval submission for Alzheimer’s candidate donanemab during Q1 following the CMS draft coverage decision for amyloid-targeting therapies.

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Lilly hopes confirmatory Phase III data will change CMS's view on amyloid-lowering drugs

The narrow possibilities for coverage of Alzheimer’s disease therapies under the US Centers for Medicare and Medicaid Services’ current coverage decision has eliminated the need to push for a quick accelerated approval of its Alzheimer’s candidate donanemab, Eli Lilly and Company execs told the firm’s fourth quarter and full year 2021 earnings call on 3 February. Instead, Lilly will wait for Phase III data that could be more convincing for payers, practitioners and regulators.

Lilly still intends to file for accelerated approval of its amyloid-clearing antibody donanemab in Alzheimer’s disease but has backed away from a plan to complete the regulatory filing this quarter....

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