CHMP positive for Omjjara (momelotinib) to treat myelofibrosis – GSK

On 9 November 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Omjjara from GSK, intended for the treatment of disease-related splenomegaly or symptoms in adult patients with moderate-to-severe anaemia who have primary myelofibrosis, post-polycythaemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis.

Omjjara will be available as 100 mg, 150 mg and 200 mg film-coated tablets. The active substance of Omjjara is momelotinib, an antineoplastic protein kinase inhibitor (ATC code: Not yet assigned). Its antineoplastic activity is linked to the selective inhibition of the Janus Associated Kinases (JAKs) involved in the signalling mediation of a number of cytokines and growth factors that are important for haematopoiesis and immune function.

The benefit of Omjjara is its ability to achieve reductions of 50% or greater in disease-related symptoms and 35% or more in spleen volume in the indication population. The most common side effects are diarrhoea, thrombocytopenia and nausea.