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European Commission approves tofacitinib for rheumatoid arthritis
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The European Commission has approved 5 mg twice daily tofacitinib for the treatment of moderate to severe active rheumatoid arthritis who have responded inadequately to or are intolerant of at least one disease-modifying antirheumatic drug, according to a press release.
Further, if there is an intolerance to methotrexate, tofacitinib (Xeljanz, Pfizer) can also be given as monotherapy.
“With the approval of tofacitinib, rheumatologists and patients in the [European Union] EU now have an additional treatment option for the management of rheumatoid arthritis that can be taken with or without methotrexate,” Ronald van Vollenhoven, MD, PhD, professor of Rheumatology and director of the Amsterdam Rheumatology and Immunology Center (ARC), said in the 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.”
The approval used the phase 3 ORAL program, which included more than 8 years of patient data and 21,100 patient-years of drug exposure.
Currently, Pfizer is working with the EU to support reimbursement for tofacitinib — which is now approved in more than 80 countries — and increase access.
“With a heritage of more than 60 years of providing rheumatoid arthritis treatment options, Pfizer has been a leader in helping to improve the lives of people with inflammatory conditions,” Angela Lukin, regional president of Inflammation & Immunology at Pfizer Innovative Health, said in the release. “The approval of Xeljanz in Europe demonstrates Pfizer’s ongoing commitment to developing medicines that address unmet needs for people living with chronic conditions like rheumatoid arthritis.”
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