The setback could delay a potential commercial introduction of the highly anticipated drug by at least several months, if the Food and Drug Administration eventually decides to approve it.
The FDA issued a so-called complete-response letter to Lilly for the company’s application for a speedy FDA approval of the drug, called donanemab, Lilly LLY,
The FDA asked Lilly to provide clinical data from at least 100 study subjects who received a minimum of 12 months of treatment with the drug. Lilly said it had previously submitted to the FDA results from a mid-stage study of donanemab in which fewer than 100 volunteers took at least 12 months of the drug.
Lilly said it would work with the FDA to evaluate the fastest pathway to get the drug to market. The company is running a late-stage study testing donanemab in more subjects, with results expected during the second quarter.
An expanded version of this report appears on WSJ.com.
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