Japan's Ministry of Health, Labour and Welfare (MHLW) has approved GSK plc.'s (GSK,GSK.L) Omjjara (momelotinib) for the treatment of myelofibrosis.
Myelofibrosis is a rare blood cancer that disrupts the body's normal production of blood cells because of dysregulated JAK-signal transducer and activator of transcription protein signalling.
Omjjara is approved for use in both newly diagnosed or previously treated myelofibrosis patients. 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.
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, GSK said.
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