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.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
2 mins