Rheumatoid arthritis drug gets approved by European Commission.
The European Commission (UC) today approved tofacitinib citrate (Xeljanz/Pfizer) 5mg twice daily oral tablets in combination with methotrexate (MTX) to treat moderate-to-severe active rheumatoid arthritis (RA) in adult patients who don’t response well to are intolerant to certain disease-modifying antirheumatic drugs (DMARDs).
Researchers highlighted that Xeljanz, part of a new class of therapies called Janus kinase inhibitors (JAK inhibitor), can be administered as a monotherapy if intolerant to MTX or when MTX treatment is inappropriate.
JAK inhibitors work inside the cell to disrupt a signaling pathway associated with RA inflammation.
Officials based the EC approval on a submission package including results from the phase 3 Oral Rheumatoid Arthritis trials (ORAL) global development program and real world data. Results from more than 8 years of data showed the safety and efficacy profile of Xeljanz both with and without MTX.
The most commonly reported adverse reactions during the first 3 months in controlled clinical trials (occurring in greater than or equal to 2% of patients) were upper respiratory tract infections, headache, diarrhea and nasopharyngitis.
According to Ronald van Vollenhoven, MD, PhD, Professor of Rheumatology and Director of the Amsterdam Rheumatology and Immunology Center ARC, “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. 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.”
Officials at Pfizer are currently working with European Union authorities to support reimbursement and availability of Xeljanz.