The approval was based on results from the Phase 3 MOMENTUM trial in which Omjjara met all its primary and key secondary endpoints and demonstrated a statistically significant response
GSK’s scientists working in laboratory. (Credit: GSK plc)
GSK has received the European Commission marketing authorisation for Omjjara (momelotinib) to treat patients with primary myelofibrosis who have disease-related splenomegaly or moderate to severe anaemia.
The indication also includes patients with post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus kinase (JAK) inhibitor naïve or previously administered with ruxolitinib.
Omjjara is a once-daily oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor.
The approval was based on results from the Phase 3 MOMENTUM trial and a subpopulation of adult patients with moderate to severe anaemia from the Phase 3 SIMPLIFY-1 study.
MOMENTUM assessed the safety and efficacy of momelotinib against danazol to treat and reduce key signs of myelofibrosis in an anaemic, symptomatic, JAK inhibitor-experienced population.
The trial met all its primary and key secondary endpoints, demonstrating statistically significant responses concerning constitutional symptoms, splenic reduction and transfusion independence.
GSK oncology global product strategy senior vice president Nina Mojas 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.”
In September 2023, the US Food and Drug Administration (FDA) approved momelotinib for patients with intermediate- or high-risk myelofibrosis.
In a similar development, the British drug maker said that the European Medicines Agency (EMA) has accepted its regulatory application to expand the use of its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine, Arexvy, on adults aged 50-59 who are at increased risk.
Upon approval, Arexvy is expected to become the first vaccine available to help protect this population.
Currently, it is authorised in Europe for adults aged 60 and over to prevent RSV-caused lower respiratory tract disease (LRTD).
This regulatory submission follows the positive data from a late-stage trial that assessed the immune response and safety of GSK’s RSV vaccine in this population.