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GSK’s new drug application for momelotinib accepted by FDA

Published on 18/08/22 at 11:25am

The potential drug treatment is for myelofibrosis patients with anaemia

UK-based GSK has announced that the US Food and Drug Administration (FDA) has accepted a new drug application (NDA) for momelotinib.

The therapy 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. The FDA has assigned a Prescription Drug User Fee Act action date of 16 June 2023.

The NDA is based on the results from key phase 3 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.

MOMENTUM is a global, randomised, double-blind phase 3 clinical trial of momelotinib versus danazol in patients with myelofibrosis who were symptomatic and anaemic and had been previously treated with an FDA-approved JAK inhibitor.

The trial was designed to evaluate the safety and efficacy of momelotinib for treating and reducing key hallmarks of the disease.

The trial's primary efficacy endpoint was TSS reduction of more than 50% over the 28 days immediately before the end of week 24 compared to baseline TSS.

Momelotinib was most recently developed by Sierra Oncology, which GSK acquired in July 2022, building on GSK’s experience in haematology and portfolio of specialty medicines and vaccines. Momelotinib is not currently approved in any market.

John Pinching

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