Posted by Michael Wonder on 17 Aug 2022
US FDA accepts new drug application for GSK’s momelotinib for the treatment of myelofibrosis
17 February 2022 - Regulatory submission included data from the pivotal MOMENTUM Phase 3 clinical trial that met all primary and key secondary efficacy outcomes.
GSK today announced that the US FDA accepted the new drug application for momelotinib, a potential new medicine with a proposed differentiated mechanism of action that may address the significant unmet medical needs of myelofibrosis patients with anaemia.
The US FDA has assigned a Prescription Drug User Fee Act action date of 16 June 2023.
