LONDON (dpa-AFX) - 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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