CHMP, positive opinion on Olumiant, an inhibitor of Janus kinase 1 and 2, for the treatment of rheumatoid arthritis
The Committee for Medicinal Products for Human Use ( CHMP ) of EMA ( European Medicines Agency ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Olumiant, intended for the treatment of rheumatoid arthritis.
Olumiant is available as 2 mg and 4 mg film-coated tablets.
The active substance of Olumiant is Baricitinib, a selective and reversible inhibitor of Janus kinase ( JAK ) 1 and 2. Janus kinases are enzymes that transduce intracellular signals from cell surface receptors for a number of cytokines and growth factors involved in haematopoiesis, inflammation and immune function.
Olumiant reduces the symptoms of rheumatoid arthritis.
The most common side effects are increased LDL cholesterol, upper respiratory tract infections and nausea.
The full indication is: Olumiant is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs.
Olumiant may be used as monotherapy or in combination with Methotrexate.
Olumiant will be prescribed by physicians experienced in the diagnosis and treatment of rheumatoid arthritis. ( Xagena )
Source: EMA; 2016