EU CHMP recommends approval of Xeljanz (tofacitinib citrate) for rheumatoid arthritis- Pfizer

The EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Xeljanz (tofacitinib citrate), from Pfizer, intended for the treatment of rheumatoid arthritis. Xeljanz will be available as 5-mg film-coated tablets. The benefits with Xeljanz are its ability to reduce the signs and symptoms of rheumatoid arthritis and to improve physical function. Xeljanz has the potential to slow the progression of joint damage in patients with rheumatoid arthritis. The most common side effects are headache, upper respiratory tract infections, nasopharyngitis, diarrhoea, nausea and hypertension.

Comment: The full indication is: Xeljanz in combination with methotrexate (MTX) 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. Xeljanz can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate.