Lilly to seek accelerated FDA approval for Alzheimer's drug this year
- The FDA granted donanemab a breakthrough therapy designation, meant to expedite the development and review of medicines for serious or life-threatening conditions.
Eli Lilly and Co said on Thursday it will apply for US health regulator's accelerated approval for its experimental Alzheimer's drug this year, sending its shares up about 8% before the bell.
The news comes weeks after Biogen Inc Alzheimer's drug, Aduhelm, was approved under the US Food and Drug Administration's accelerated approval pathway, for which the agency came under intense criticism as questions were raised on the strength of the clinical data.
Lilly said in January early results from a mid-stage trial showed the drug, donanemab, slowed the rate of decline in cognition and function in patients at an early stage of the mind-wasting disease.
The drugmaker said it intends to file the marketing application based on data from the mid-stage trial. It is also currently testing donanemab in a late-stage study.
The FDA granted donanemab a breakthrough therapy designation, meant to expedite the development and review of medicines for serious or life-threatening conditions.
A drug with that designation can become eligible for FDA's accelerated approval pathway, if the relevant criteria are met.
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