European Commission approves Omjjara (momelotinib) indicated for treating splenomegaly (enlarged spleen) or symptoms in adult myelofibrosis patients with moderate to severe anaemia

Omjjara is the first authorised medicine in the EU for disease-related splenomegaly (enlarged spleen) 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.

Nina Mojas, Senior Vice President, Oncology Global Product Strategy, GSK, said: “The challenges of living with myelofibrosis can be burdensome, and symptomatic patients can experience spleen enlargement, fatigue, night sweats and bone pain. Until now, there have been no options specifically indicated to treat these symptoms in patients who also experience anaemia. The authorisation of Omjjara brings a new treatment option with a differentiated mechanism of action to these patients in the EU.”

Francesca Palandri, MD, PhD, IRCCS S. Orsola-Malpighi, Bologna University Hospital, Italy, said: “The EU authorisation of Omjjara represents a meaningful advancement for eligible patients with myelofibrosis, and particularly for those with moderate to severe anaemia who need new treatment options that may reduce their disease-related burden. The availability of a single therapy for key manifestations of myelofibrosis is a clear step forward for eligible patients.”