GSK Announces Extension of FDA Review Period for Momelotinib
After all, GSK will not hear from the FDA this month about its marketing application for momelotinib as a therapy for anemia in myelofibrosis patients. The pharmaceutical company announced that the US Food and Drug Administration has extended the drug's assessment period by three months, to September 16, "to allow time to review recently submitted data." GSK has not provided any additional information regarding the new data, but it says it is "confident" in the application and "looks forward to working with the FDA as they finalise their review."
Momelotinib, which was the lead asset in GSK's $1.9 bill...
