Omjjara (momelotinib)
OrphanAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- momelotinib
- Company
- GlaxoSmithKline Trading Services Limited
- Status
- Authorised
- Therapeutic area
- Splenomegaly; Myeloproliferative Disorders
- CHMP opinion
- Thu 09 Nov 2023
- EU approval
- Thu 25 Jan 2024
- Designations
- Orphan, Additional monitoring
- Application
- EMEA/H/C/005768
- Official record
- www.ema.europa.eu
Indication
Omjjara is indicated 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 and who are Janus Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.