Tofacitinib is a selective Janus kinase inhibitor approved in more than 50 countries. It will be available in 5-mg film-coated tablets.
Pfizer said the drug can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is not appropriate.
The company’s marketing authorisation application included data from the Oral Rheumatoid Arthritis Phase 3 TriaLs (ORAL) global development program, which included six completed clinical studies.
Xeljanz is capable of reducing the indications and symptoms of RA and to enhance physical function.
It also has the potential to slow the progression of joint damage in RA patients.
Pfizer chief development officer of inflammation & immunology, global product development Michael Corbo said: “More than 2.9 million people are currently living with moderate to severe rheumatoid arthritis in Europe. Even with multiple therapeutic options, many of these people may not adequately respond to currently available treatments, including methotrexate.
“The positive CHMP opinion for tofacitinib is an important milestone as we work to bring this new oral treatment option to people in the European Union living with moderate to severe active rheumatoid arthritis.”
Image: Pfizer World Headquarters New York City. Photo: courtesy of Norbert Nagel, Mörfelden-Walldorf, Germany.