The Committee for Medicinal Products for Human Use (CHMP) is recommending the approval of Pfizer’s Xeljanz (tofacitinib citrate, 5 mg tablets twice daily) as a treatment for adults with moderate-to-severely active rheumatoid arthritis (RA) in the European Union.
The European Commission (EC) will now review the CMPH opinion and issue a final decision. If approved, Xeljanz in combination with methotrexate will be indicated as a second-line therapy for patients with moderate to severe RA, after the failure of one or more disease-modifying anti-rheumatic drugs (DMARDs). Xeljanz can also be given alone in patients who fail or whose response to methotrexate is inappropriate.
“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,” Michael Corbo, chief development officer, Inflammation & Immunology, Global Product Development at Pfizer, said in a press release. “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.”
The marketing authorization application (MAA) submitted by Pfizer to European Medicines Agency, of which CMPH is a part, included data from Xeljanz’s clinical development program in RA, which spanned six completed trials: ORAL Start, ORAL Solo, ORAL Standard, ORAL Sync, ORAL Scan and ORAL Step, as well as two open-label extension (LTE) trials.
The ORAL clinical development program has collected data on more than 19,400 patient-years of drug exposure, having been investigated in more than 6,100 patients, including follow-up observations of up to eight years in the extension trials.
Xeljanz has been approved in more than 50 countries for the treatment of patients with a diagnosis of moderate to severe RA as a second-line therapy after failure of one or more DMARDs. Tofacitinib was first approved in the U.S. in 2012.
Xeljanz, which belongs to a class of drugs known as janus kinase (JAK) inhibitors, is now included in the 2015 American College of Rheumatology (ACR) guidelines. ACR is a professional membership organization dedicated to improving the care of patients with rheumatic diseases, including RA.