The European Commission (EC) approval follows a positive recommendation made in January by the Committee for Medicinal Products for Human Use (CHMP). Xeljanz (5 mg, twice daily) may now be used in combination with methotrexate (MTX) as a second-line therapy for patients with moderate to severe RA in case one or more disease-modifying anti-rheumatic drugs (DMARDs) fails. Xeljanz can also be given as a monotherapy in patients who fail or whose response to MTX is inappropriate.
The EC based its approval on a package submitted by Pfizer, which included results from six clinical trials as part of the ORAL drug clinical development program in RA: ORAL Start, ORAL Solo, ORAL Standard, ORAL Sync, ORAL Scan and ORAL Step, as well as two open-label extension (LTE) studies.
The ORAL program includes over eight years of safety data from the extension trials, representing more than 21,100 patient-years of drug exposure to date. The data demonstrated the safety and effectiveness of Xeljanz, both with and without MTX, for treatment of moderate to severe RA.
“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,” Ronald van Vollenhoven, director of the Amsterdam Rheumatology and Immunology Center, said in a press release. “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.”
In February 2016, the U.S. Food and Drug Administration approved Xeljanz XR (tofacitinib citrate) extended-release 11 mg tablets as a once-daily treatment for the same clinical population. With EU approval in the EU, Xeljanz may now be used in more than 80 countries worldwide.
Xeljanz, a janus kinase inhibitor, is included in the 2015 guidelines of the American College of Rheumatology, which works to improve care for patients with RA and other rheumatic diseases.
“Pfizer has been a leader in helping to improve the lives of people with inflammatory conditions,” said Angela Lukin, regional president of Pfizer Innovative Health’s inflammation and immunology division, adding that the EU’s approval of Xeljanz demonstrates her company’s resolve to develop medicines “that address unmet needs” for RA and other chronic illness patients.
An estimated 17.6 million people worldwide have RA, including more than 2.9 million Europeans. It can develop at any time during adulthood, but it usually occurs between 40 and 70 years of age, and usually among women.