GSK PLC on Monday announced that a European Medicines Agency panel has given a positive opinion recommending momelotinib to treat myelofibrosis patients with anaemia.
The opinion from the Committee for Medicinal Products for Human Use, London-based GSK said, is one of the final steps paving the way to a marketing authorisation decision from the European Commission.
GSK said that if momelotinib is approved, it will become the only medicine specifically indicated in the EU for both newly diagnosed and previously treated myelofibrosis patients with moderate to severe anaemia.
Myelofibrosis, GSK explained, is a rare blood cancer that disrupts the body’s normal production of blood cells, with ‘nearly all’ patients estimated to develop anaemia during the course of the disease. Patients who depend on transfusions to treat anaemia ‘have a poor prognosis and shortened survival’.
The pharmaceutical manufacturer said the CHMP opinion was supported by data from the Momentum global Phase 3 trial, which ‘met all its primary and key secondary endpoints, demonstrating statistically significant response with respect to constitutional symptoms, splenic response and transfusion independence, in patients treated with momelotinib versus danazol.’
GSK said momelotinib will be available under the proposed trade name Omjjara, should it receive EU approval. It was approved under the brand name Ojjara by the US Food & Drug Administration in September.
‘Momelotinib has a differentiated mechanism of action that may address the significant medical needs of myelofibrosis patients, especially those with moderate to severe anaemia,’ said Nina Mojas, GSK’s senior vice president of Oncology Global Product Strategy. ‘The vast majority of myelofibrosis patients will develop anaemia, causing them to require transfusions and leading a notable proportion to discontinue treatment.
‘This positive CHMP opinion is a significant step in bringing momelotinib to patients in the EU with this difficult-to-treat blood cancer.’
GSK shares were up 1.1% at 1,413.20 pence in London on Monday morning.
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