Drug Approval | November 21, 2023
GSK receives positive CHMP opinion recommending momelotinib for myelofibrosis patients with anaemia
Decision on EU marketing authorisation expected for momelotinib by early 2024
Decision on EU marketing authorisation expected for momelotinib by early 2024
48-week data from MOMENTUM phase III clinical trial show momelotinib maintained total symptom response
Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints
Approval is for use in myelofibrosis patients with anaemia regardless of prior myelofibrosis therapy
Momelotinib complements GSK’s existing expertise in haematology, with Sierra Oncology anticipating US regulatory submission in Q2 this year and EU submission in the second half of 2022
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