Pfizer will be celebrating news that its rheumatoid arthritis drug Xeljanz has been issued a green light in Switzerland, particularly as its approval within the European Union is currently looking unlikely.
Regulatory agency Swissmedic has approved Xeljanz (tofacitinib 5mg and 10mg twice-daily) as a monotherapy or in combination with a disease modifying non-biologic antirheumatic agent (DMARD) in adult patients with moderate-to-severe active RA, but only in those who have had an inadequate response or intolerance to methotrexate.
The decision will raise some eyebrows given that, back in April, the European Medicine Agency’s Committee for Medicinal Products for Human Use did not recommend the drug’s approval in this setting.
The CHMP said Xeljanz helps improve the signs and symptoms of RA and the physical function of patients, but that it “did not believe that a consistent reduction in disease activity and structural damage to joints had been sufficiently demonstrated”.
It also voiced concern about the serious infections, gastrointestinal perforations and malignancies observed in trials, and thus felt that Xeljanz failed to demonstrate a favourable risk:benefit profile based on the current data.
Pfizer is already on the route of appeal, seeking a re-examination of the decision, and is currently working with the CHMP on the next steps in the process.
The data package submitted to the EMA, which included 5,000 patients across Phase II and III trials across more than 40 countries, was the same as that handed to US regulators, which approved Xeljanz back in November.
So far, the drug has also been given clearance in Japan (with a launch expected this month), Russia (where it is marketed as Jaquinus), Argentina, Kuwait and the United Arab Emirates, and analysts are expecting its oral administration – as opposed to the injection route of other biologics – could give it a competitive edge over its rivals.
