(RTTNews) - British drug maker GSK plc (GSK, GSK.L) announced Wednesday that the US Food and Drug Administration accepted the New Drug Application or NDA for momelotinib for the treatment of myelofibrosis.
Myelofibrosis is a rare blood cancer that results from dysregulated JAK-signal transducer and activator of transcription protein signalling. It is characterised by constitutional symptoms, splenomegaly, and progressive anaemia.
Momelotinib is a potential new medicine with a proposed differentiated mechanism of action that may address the significant unmet medical needs of myelofibrosis patients with anaemia. Momelotinib is not currently approved in any market.
The FDA has assigned a Prescription Drug User Fee Act action date of June 16, 2023.
The company noted 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. These included Total Symptom Score or TSS, Transfusion Independence or TI rate and Splenic Response Rate or 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.
Momelotinib was most recently developed by Sierra Oncology, Inc., which GSK acquired in July 2022.
For More Such Health News, visit rttnews.com
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
