GSK's Omjjara Secures Japanese Nod For Treatment of Myelofibrosis

GSK plc, a biotechnology company, reported that Japan's Ministry of Health, Labour and Welfare (MHLW) has endorsed Omjjara (momelotinib) for the treatment of myelofibrosis. Omjjara is an oral, once-daily inhibitor of JAK1/JAK2 and the activin A receptor type 1 (ACVR1). The endorsement depends on information from the pivotal phase III MOMENTUM and SIMPLIFY-1 trials.

Following approvals under the brand name Omjjara from the European Commission and the Medicines and Healthcare Products Regulatory Agency in the UK, as well as approvals under the brand name Ojjaara from the US Food and Drug Administration, this is the fourth major regulatory approval for GSK's momelotinib in the treatment of myelofibrosis.

Nina Mojas, senior vice president, oncology global product strategy, GSK, said: “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 approval is based on the results of the pivotal phase III clinical trials MOMENTUM and SIMPLIFY-1. Energy was intended to assess the security and viability of momelotinib versus danazol for the treatment and decrease of key signs of myelofibrosis in a anaemic, symptomatic, JAK inhibitor-experienced population. SIMPLIFY-1 was developed to examine momelotinib and ruxolitinib's efficacy and safety in patients with myelofibrosis who had not previously been treated with a JAK inhibitor.