Pfizer gets Swiss nod for Xeljanz for rheumatoid arthritis

US drug giant Pfizer (NYSE: PFE) said its rheumatoid arthritis (RA) therapy Xeljanz (tofacitinib) has received approval in Switzerland – the first European country to clear the product.

Swissmedic, the Swiss agency for therapeutic products, approved Xeljanz 5mg and 10mg twice-daily (BID) as monotherapy or in combination with a disease modifying non-biologic antirheumatic agent (DMARD), including methotrexate(MTX), in adult patients with moderate-to-severe active RA who have had an inadequate response or intolerance to MTX.

Geno Germano, president and general manager, Specialty Care and Oncology, at Pfizer, said: “More than 23 million people worldwide are living with rheumatoid arthritis and there remains an unmet need for additional treatments, with up to one-third of RA patients not adequately responding and about half who stop responding to any particular DMARD within five years.  Xeljanz has a novel mechanism of action for the treatment of moderate-to-severe RA. With these approvals, we believe Xeljanz has the potential to change the way rheumatologists treat this chronic, and potentially disabling, disease, and we are proud to offer patients and physicians an additional treatment option.”