GSK's Rare Blood Cancer Candidate Goes Under FDA Review

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  • The FDA has accepted GSK plc's GSK marketing application for momelotinib, a potential new medicine with a proposed differentiated mechanism of action for myelofibrosis patients with anemia. 
  • Myelofibrosis is a rare blood cancer.
  • The U.S. FDA has assigned a Prescription Drug User Fee Act action date of 16 June 2023.
  • The application is based on the results from crucial Phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary endpoints.
  • The trial's primary efficacy endpoint was a reduction in symptom severity score of ≥50% over the 28 days immediately before the end of Week 24 compared to baseline. 
  • Key secondary endpoints included Transfusion Independence rate for ≥12 weeks immediately before the end of Week 24 with hemoglobin levels ≥ 8 g/dL and Splenic Response Rate based on splenic volume reduction of ≥35% at Week 24 from baseline.
  • Price Action: GSK shares are down 2.55% at $34.37 during the premarket session on the last check Wednesday.
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