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Lilly Waiting On Phase III Data For Donanemab

 
• By Joseph Haas

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...

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