GSK has received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Omjjara (momelotinib) to treat patients with myelofibrosis.
Omjjara is a once-daily oral Janus kinase (JAK)1/JAK2 and activin receptor type-1 (ACVR1) inhibitor.
The development marks the fourth major regulatory approval for the asset, following its clearance in the US, the European Union and the UK.
The MHLW granted the approval based on results from the MOMENTUM and SIMPLIFY-I Phase III trials.
MOMENTUM focused on comparing momelotinib’s safety and efficacy against danazol in anaemic, symptomatic patients who had previously been treated with a JAK inhibitor.
The SIMPLIFY-I trial assessed the safety and efficacy of momelotinib versus ruxolitinib in patients who had not previously received JAK inhibitor therapy.
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By GlobalData
In September 2023, the US Food and Drug Administration (FDA) licensed momelotinib under the Ojjaara brand name for intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis in adult patients with anaemia.
The European Commission granted marketing authorisation for Omjjara in January 2024 to address disease-related splenomegaly or symptoms in adults with moderate to severe anaemia.
GSK oncology global product strategy senior vice-president Nina Mojas stated: “Myelofibrosis has a heavy disease burden, with symptomatic patients experiencing spleen enlargement, fatigue, night sweats and bone pain, along with anaemia which can lead to treatment discontinuation and dependence on regular blood transfusions.
“With the approval of Omjjara, myelofibrosis patients in Japan will have a new treatment option for this complex blood cancer.”
The FDA recently expanded the age indication for GSK’s Arexvy, making it the first vaccine against respiratory syncytial virus available for adults aged 50 to 59 years at higher risk of lower respiratory tract disease.
