GSK Omjjara gets European Commission marketing authorisation
London: GSK plc has announced the European Commission has granted marketing authorisation for Omjjara (momelotinib), a once-a-day, oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor.
"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," the Company stated.
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.”
Myelofibrosis is estimated to affect 1 in 10,000 people in the EU. About 40% of patients have moderate to severe anaemia at the time of diagnosis and nearly all patients are estimated to develop anaemia over the course of the disease. Myelofibrosis patients with anaemia require additional supportive care, including transfusions, and more than 30% will discontinue treatment due to anaemia. Patients who are transfusion dependent have a poor prognosis and shortened survival.
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.”
The authorisation of momelotinib is based on the MOMENTUM pivotal phase III trial and a subpopulation of adult patients with moderate to severe anaemia (haemoglobin <10 g/dL) from the SIMPLIFY-1 phase III trial. MOMENTUM was designed to evaluate the safety and efficacy of momelotinib versus danazol for the treatment and reduction of key manifestations of myelofibrosis in an anaemic, symptomatic, JAK inhibitor-experienced population. SIMPLIFY-1 was designed to evaluate the efficacy and safety of momelotinib versus ruxolitinib in myelofibrosis patients who had not received a prior JAK-inhibitor therapy.
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