Momelotinib (brand name Omjjara) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat adult myelofibrosis patients who have anaemia.
The Janus kinase (JAK) inhibitor is now 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 naive or have been treated with ruxolitinib.
The MHRA approval follows the positive opinion from the European Medicines Agency‘s Committee for Medicinal Products for Human Use in November 2023 for the same indication.
Momelotinib is taken in tablet form, once daily, at the same time each day.
Julian Beach, MHRA interim executive director, healthcare quality and access, said: ‘Myelofibrosis patients often rely on blood transfusions to counter their anaemia, but studies have shown that these transfusions are often linked to reduced quality of life and survival.
‘Keeping patients safe and enabling their access to high quality, safe and effective medical products are key priorities for us.
‘We’re assured that the appropriate regulatory standards for the approval of this medicine have been met.’
He added: ‘As with all products, we will keep the safety of this medicine under close review.’
Statistically significant response for momelotinib
This approval is supported by evidence from the randomised, double-blind phase 3 MOMENTUM trial involving 195 patients with myelofibrosis and anaemia, who had previously been treated with a JAK inhibitor.
The patients were given either 200mg momelotinib once daily, or 300mg of danazol twice daily, for 24 weeks.
Momelotinib demonstrated a statistically significant response with respect to constitutional symptoms, splenic response and transfusion independence compared to danazol at Week 24.
Some 25% of patients on momelotinib saw their symptoms reduce by at least half (against 9% on danazol) and 22% saw their enlarged spleen volume decrease by at least 35% (against 2% on danazol).
Momelotinib was also associated with favourable safety at Week 48 in a follow-up analysis.
The most common adverse reactions were diarrhoea, thrombocytopaenia, nausea, headache, dizziness, fatigue, asthenia, abdominal pain and cough.
