GSK announces Omjjara approved in Japan for myelofibrosis

GSK plc announced that Japan’s Ministry of Health, Labour and Welfare, or MHLW, has approved Omjjara for the treatment of myelofibrosis. Omjjara is a once-a-day, oral JAK1/JAK2 and activin A receptor type 1 inhibitor. The approval is based on data from the pivotal phase III MOMENTUM and SIMPLIFY-1 trials. “This is the fourth major regulatory approval for GSK‘s momelotinib in the treatment of myelofibrosis, following approval under the brand name Ojjaara from the US Food and Drug Administration and authorisations under the brand name Omjjara from the European Commission and the Medicines and Healthcare products Regulatory Agency in the UK,” the company stated. 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.”