The European Medicines Agency (EMA) committee has recommended the authorization of GlaxoSmithKline’s (GSK) oral therapy to treat myelofibrosis, a rare type of blood cancer that affects the bone marrow. The announcement was made by GSK on a Monday.
This oral therapy offers a possible new treatment alternative for patients diagnosed with myelofibrosis in the European Union.
The EMA, through its Committee for Medicinal Products for Human Use (CHMP), has proposed approval of Omjjara (momelotinib), manufactured by GSK, for the treatment of splenomegaly and symptoms associated with this disease in adults with moderate to severe anemia who have primary myelofibrosis , post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis, and who have not previously received Janus Kinase (JAK) inhibitors or not been treated with ruxolitinib.
The drug will be available as film-coated tablets in 100 mg, 150 mg and 200 mg variants. The active substance, momelotinib, is an antineoplastic protein kinase inhibitor.
Momelotinib works by selectively inhibiting Janus-associated kinases (JAKs), which are involved in signaling for several cytokines and growth factors essential for hematopoiesis and immune function.
According to the CHMP review, the drug’s benefits include reducing disease-related symptoms by at least 50% and reducing spleen volume by at least 35% in the target population.
The most common side effects identified are diarrhea, thrombocytopenia and nausea. The final authorization decision belongs to the European Commission, which usually follows the recommendations of the EMA specialists.
Source: 360medical.ro
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2023-11-26 17:53:47
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