GSK's Omjjara Authorized in EU for Treating Myelofibrosis With Anemia

By Joe Hoppe

GSK said its Omjjara medicine for the treatment of splenomegaly--an enlarged spleen--or symptoms in adult myelofibrosis patients with moderate to severe anemia has been authorized for marketing in the European Union.

The British pharmaceutical giant said the European Commission's authorization of the drug, also known as momelotinib, may address high unmet need, as nearly all myelofibrosis patients develop anemia over the course of the disease.

Myelofibrosis is believed to affect around 1 in 10,000 people in the European Union. Around 40% of patients have moderate to severe anemia at the time of diagnosis, and patients with anemia require additional supportive care, including transfusions.

More than 30% of patients will discontinue treatment due to anemia, and patients who are transfusion dependent have a poor prognosis and shortened survival.

"The challenges of living with myelofibrosis can be burdensome, and symptomatic patients can experience spleen enlargement, fatigue, night sweats and bone pain. Until now, there have been no options specifically indicated to treat these symptoms in patients who also experience anemia," said Nina Mojas, senior vice president of GSK's Oncology Global Product Strategy.

The authorization of Omjjara is based on the MOMENTUM pivotal Phase 3 trial.

Write to Joe Hoppe at joseph.hoppe@wsj.com

(END) Dow Jones Newswires

January 29, 2024 02:31 ET (07:31 GMT)

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