The GSK plc (LON: GSK) share price edged 1.12% higher after announcing that it had received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) regarding its momelotinib drug candidate for treating myelofibrosis in patients with moderate to severe anaemia.
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The CHMP recommended the approval of momelotinib for the treatment of disease-related splenomegaly (enlarged spleen) or symptoms in adult patients suffering from moderate to severe anaemia with primary myelofibrosis, post-polycythaemia vera myelofibrosis, or post-essential thrombocythaemia myelofibrosis.
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The recommendation also extends to patients who are either Janus kinase (JAK) inhibitor naive or have been previously treated with ruxolitinib. The CHMP’s favourable opinion marks a crucial step towards obtaining marketing authorisation from the European Commission.
If granted approval, momelotinib will become the only medication in the European Union (EU) expressly indicated for newly diagnosed and previously treated myelofibrosis patients grappling with moderate to severe anaemia while addressing splenomegaly and associated symptoms.
The positive CHMP opinion is supported by data from the pivotal MOMENTUM study and a subpopulation of adult patients with moderate to severe anaemia (haemoglobin <10 g/dL) from the SIMPLIFY-1 phase III trial.
On the other hand, SIMPLIFY-1 aimed to evaluate the efficacy and safety of momelotinib versus ruxolitinib in myelofibrosis patients who had not previously received JAK-inhibitor therapy.
Common adverse reactions observed in these clinical trials included thrombocytopenia, diarrhoea, headache, nausea, fatigue, dizziness, abdominal pain, asthenia, and cough.
If momelotinib receives approval in the EU, it will be marketed under the proposed trade name “Omjjara.” The positive development follows the earlier approval of momelotinib under the ” Ojjaara ” brand by the US Food and Drug Administration (FDA) in September 2023.
Nina Mojas, Senior Vice President of Oncology Global Product Strategy, GSK, said: “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. This positive CHMP opinion is a significant step in bringing momelotinib to patients in the EU with this difficult-to-treat blood cancer.”
GSK share price.
The GSK share price edged 1.12% higher to trade at 1415.60p from Friday’s closing price of 1399.90p.
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