US FDA accepts New Drug Application for GSK’s momelotinib for treatment of myelofibrosis
Regulatory submission included data from the pivotal Momentum phase-III clinical trial that met all primary and key secondary efficacy endpoints
The US Food and Drug Administration (FDA) accepted the New Drug Application (NDA) 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 16th June, 2023, GSK informed via a statement recently.
The statement also said that the NDA is based on the results from key phase-III trials, including the pivotal Momentum trial, which met all primary and key secondary endpoints, including Total Symptom Score (TSS), Transfusion Independence (TI) rate and Splenic Response Rate (SRR). The primary analysis data from the Momentum trial were recently presented at the 2022 American Society of Clinical Oncology Annual Meeting and the European Hematology Association 2022 Hybrid Congress.
Further, according to the statement, Momelotinib is not currently approved in any market.
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