European Drug Regulator Recommends Approval Of GSK's Bone Marrow Cancer Med

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending approval of GSK plc's GSK momelotinib for disease-related splenomegaly (enlarged spleen) or symptoms in bone marrow cancer patients.

The opinion covers adult patients with moderate to severe anemia who have primary myelofibrosis, post polycythemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus kinase inhibitor naïve or have been treated with ruxolitinib.

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If approved, momelotinib would be the only medicine in the European Union specifically indicated for newly diagnosed and previously treated myelofibrosis patients with moderate to severe anemia that addresses splenomegaly and symptoms.

The positive CHMP opinion is supported by data from the MOMENTUM study and a subpopulation of adult patients with moderate to severe anemia from the SIMPLIFY-1 phase 3 trial.

Momelotinib will be available under the proposed trade name Omjjara if approved in the EU. This opinion follows the September 2023 approval of momelotinib under the brand Ojjaara by the FDA for intermediate or high-risk myelofibrosis.

Price Action: GSK shares are up 0.36% at $34.54 on the last check Monday.