Pfizer bags approval for RA drug Xeljanz

Some patients with moderate to severe forms of rheumatoid arthritis could get access to a new treatment option in Europe following the approval of Pfizer’s oral Janus kinase (JAK) inhibitor Xeljanz.

Xeljanz (tofacitinib) has now been cleared by the European Commission in combination with methotrexate for treatment of patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying antirheumatic drugs (DMARDs).

The regulator is also allowing the drug’s use as a monotherapy if patients can’t tolerate methotrexate or when treatment with it is inappropriate.

"With the approval of tofacitinib, rheumatologists and patients in the EU now have an additional treatment option for the management of rheumatoid arthritis that can be taken with or without methotrexate," said Ronald van Vollenhoven, professor of Rheumatology and Director of the Amsterdam Rheumatology and Immunology Center ARC.

"This is an important advancement for the rheumatology community as up to one-third of people with rheumatoid arthritis may not achieve a response with current treatments and a number of patients may not sustain a response."

Back in 2013, the European Medicine Agency's Committee for Medicinal Products for Human Use did not recommend the drug's approval 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".

But in January this year the Committee concluded that the drug is able to reduce the signs and symptoms of RA and improve physical function and, crucially, also has the potential to slow the progression of joint damage in patients with the condition.

RA affects around 17.6 million people worldwide and more than 2.9 million people in Europe.