FDA squash­es ac­cel­er­at­ed hopes for Eli Lil­ly’s Alzheimer’s drug as agency asks for more da­ta

The FDA flashed a red light on Eli Lil­ly’s in­ves­ti­ga­tion­al Alzheimer’s drug do­nanemab, spurn­ing hopes of two new med­ica­tions for the dis­ease this month.

The Big Phar­ma put out word af­ter the mar­kets closed Thurs­day say­ing the US reg­u­la­tor de­nied the ac­cel­er­at­ed ap­proval “based on lim­it­ed num­ber of pa­tients with 12-month drug ex­po­sure da­ta” in the sub­mis­sion. Pa­tients in the tri­al were al­lowed to wean off treat­ment once a cer­tain amount of amy­loid pro­tein was cleared from their brains, mean­ing some pa­tients did not re­ceive the study drug for 12 months. “No oth­er de­fi­cien­cies were iden­ti­fied,” Lil­ly said in a state­ment.

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Venture & Research Associate

Alexandria Real Estate Equities

San Francisco, CA, USA