Eight medicines leap towards EU approval
Eight medicines – including two biosimilars – have taken a giant step towards being approved for the European market having won favour with the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
Approval of Pfizer’s oral Janus kinase (JAK) inhibitor Xeljanz (tofacitinib) has been recommended as a treatment for rheumatoid arthritis (RA).
According to the Committee, the drug’s benefits are its ability to reduce the signs and symptoms of RA and to improve physical function, and also has the potential to slow the progression of joint damage in patients with the condition.
Back in 2013 the drug was not recommended by CHMP for RA, on grounds that it “did not believe that a consistent reduction in disease activity and structural damage to joints had been sufficiently demonstrated”.