GSK one step closer to momelotinib approval in EU

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of momelotinib, GSK announced on Monday.

Momelotinib, which would have a trade name of Omjjara, is hoped to be used for the "treatment of disease-related splenomegaly (enlarged spleen) or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus kinase (JAK) inhibitor naïve or have been treated with ruxolitinib", the company explained.

The CHMP opinion is one of the final steps prior to a marketing authorisation decision by the European Commission. If approved, GSK's treatment would be the only medicine in the EU specifically indicated for both newly diagnosed and previously treated myelofibrosis patients with moderate to severe anaemia that addresses splenomegaly (enlarged spleen) and symptoms.

"This positive CHMP opinion is a significant step in bringing momelotinib to patients in the EU with this difficult-to-treat blood cancer," said Nina Mojas, the senior vice president of GSK's Oncology Global Product Strategy unit.

"Momelotinib has a differentiated mechanism of action that may address the significant medical needs of myelofibrosis patients, especially those with moderate to severe anaemia. The vast majority of myelofibrosis patients will develop anaemia, causing them to require transfusions and leading a notable proportion to discontinue treatment."