FDA extends review period for GSK's momelotinib

The US Food and Drug Administration (FDA) has extended the review period of the new drug application (NDA) for momelotinib by three months to provide time to review recently submitted data, according to a stock exchange filing by UK pharma major GSK (LSE: GSK). The extended action date is September 16, 2023.

THE FDA accepted its New Drug Application (NDA) for momelotinib for the potential treatment of myelofibrosis patients in August last year.  GSK says it is confident in the momelotinib NDA and looks forward to working with the agency as it finalizes the review.

Momelotinib was most recently developed by Sierra Oncology, which GSK acquired for around $1.9 billion in July 2022, building on GSK’s expertise in hematology and portfolio of specialty medicines and vaccines.