The European Commission Approves GSK’s Omjjara (momelotinib) for the Treatment of Severe Anaemia
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- The marketing authorisation was granted based on two P-III pivotal clinical trials evaluating the safety & efficacy of Omjjara vs danazol in (MOMENTUM) & vs ruxolitinib in the (SIMPLIFY-1) trial as a treatment of myelofibrosis patients (n=195 & 432)
- The (MOMENTUM) trial met both the 1EP & 2EP depicting a total symptom score reduction of ≥50% & 25% (momelotinib) vs 9% (danazol) whereas the (SIMPLIFY-1) study showed a reduction in spleen volume by ≥35% & 31% (momelotinib) vs 33% (ruxolitinib)
- Omjjara (momelotinib) is a JAK1/JAK2 & ACVR1 inhibitor approved for the treatment of disease-related splenomegaly or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis
Ref: GSK | Image: GSK
Related News:- GSK Receives the US FDA’s Approval of Ojjaara (momelotinib) for Myelofibrosis Patients with Anemia
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Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
