GSK’s Omjjara approved in Japan for treatment of myelofibrosis

Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved Omjjara (momelotinib) for the treatment of myelofibrosis, UK pharma major GSK (LSE: GSK) announced today.

Omjjara is a once-a-day, oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor. The approval is based on data from the pivotal phase III MOMENTUM and SIMPLIFY-1 trials.

The company noted that 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 authorizations under the brand name Omjjara from the European Commission and the Medicines and Healthcare products Regulatory Agency in the UK.