GSK Says FDA Accepts Momelotinib's New Drug Application

By Anthony O. Goriainoff

GSK PLC said Wednesday that momelotinib's new drug application, or NDA, has been accepted by the U.S. Food and Drug Administration for the treatment of myelofibrosis.

The U.K. pharmaceutical company said the FDA assigned a Prescription Drug User Fee Act, or PDUFA, action date of June 16, 2023.

The PDUFA refers to the date by which the agency's review process must be completed.

The FTSE 100-listed company said the NDA is based on results from key Phase 3 trials which met all primary and key secondary endpoints, and added that momelotinib wasn't currently approved in any market.

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(END) Dow Jones Newswires

08-17-22 0231ET