The news comes weeks after Biogen Inc's Alzheimer's drug, Aduhelm, was approved under the U.S. 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.
By Reuters Staff
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