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
Approval is for use in myelofibrosis patients with anaemia regardless of prior myelofibrosis therapy
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
TP-3654 is currently being evaluated in a Phase 1/2, multicenter, dose-escalation, open-label trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with intermediate or high-risk primary or secondary myelofibrosis.
Pelabresib recently met its primary endpoint of spleen volume reduction and demonstrated favorable trends in symptom improvement
SMPA's diverse portfolio includes six marketed products and a robust pipeline of early- to late-stage assets
Acquisition expands Merck’s growing hematology portfolio
CLNK is a biotechnology research and development company that utilizes umbilical cord blood as the raw material to develop innovative, allogeneic, off-the-shelf, cell based therapeutic products
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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