GSK’s Omjjara (momelotinib) has been approved by the European Commission (EC) to treat myelofibrosis patients with moderate-to-severe anaemia.
The decision makes Omjjara the first medicine authorised in the EU to treat 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.
The drug is indicated for use in both newly diagnosed patients and those previously treated with existing standard of care, although eligible patients will need to have either not been treated with JAK inhibitors before or been treated with Novartis’ Jakavi (ruxolitinib).
Estimated to affect one in 10,000 people in the EU, myelofibrosis is a rare blood cancer that can lead to severely low blood counts.
About 40% of myelofibrosis patients have moderate-to-severe anaemia at the time of diagnosis and nearly all patients develop anaemia at some point over the course of their disease.
Transfusions are often required by anaemic myelofibrosis patients and more than 30% will discontinue treatment due to anaemia.
Omjjara is a once-a-day oral JAK1/JAK2 and ACVR1 inhibitor that aims to address the key manifestations of the disease.
The EU marketing authorisation is supported by results from the pivotal MOMENTUM study, which evaluated Omjjara versus another anaemia treatment called danazol in an anaemic, symptomatic and JAK inhibitor-experienced myelofibrosis population.
The trial met all of its primary and key secondary endpoints, with Omjjara-treated patients showing improved symptoms, spleen size and transfusion independent compared with patients receiving danazol.
Data from a subpopulation of adult patients with moderate-to-severe anaemia from the late-stage SIMPLIFY-1 trial assessing the efficacy and safety of Omjjara versus ruxolitinib in myelofibrosis patients who had not received a prior JAK-inhibitor therapy also supported the company’s application.
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.”