EMA — authorised 25 January 2024
- Application: EMEA/H/C/005768
- Marketing authorisation holder: GlaxoSmithKline Trading Services Limited
- Local brand name: Omjjara
- 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.
- Pathway: orphan
- Status: approved
The European Medicines Agency (EMA) granted marketing authorisation for Omjjara (CYT387) on 25 January 2024. Omjjara is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis, or post essential thrombocythaemia myelofibrosis. These patients must have moderate to severe anaemia and be either JAK inhibitor naïve or have been treated with ruxolitinib.