The FDA’s approval of Xeljanz is based on Pfizer’s Phase III multicenter, double-blind, placebo-controlled study. Here are more details about the study.
Pfizer’s XELJANZ got approval from FDA. (Dan Kitwood/Getty Images)
Pfizer’s candidate treatment for patients diagnosed with active ankylosing spondylitis (AS) has been approved by the U.S. Food and Drug Administration under a supplemental New Drug Application.
The sNDA pertains to the use of XELJANZ/XELJANZ XR (tofacitinib), an oral Janus kinase (JAK) inhibitor that is already approved in the U.S. for five indications. XELJANZ is approved for patients with intolerance or insufficient response to one or more tumor necrosis factor (TNF) blockers in adults with active AS and adults with moderate to severely active psoriatic arthritis (PsA), rheumatoid arthritis (RA) and ulcerative colitis (UC). It is also indicated for children aged at least two years old who have active polyarticular course juvenile idiopathic arthritis (pcJIA).
About Pfizer’s XELJANZ Approval from FDA
The FDA’s NDA approval is based on Pfizer’s Phase III multicenter, double-blind, placebo-controlled study, which looked into the safety and efficacy of using 5 mg of tofacitinib two times a day to treat adults with active AS versus placebo.
Researchers found that it had met its primary endpoint at week 16, where those who received the drug achieved an Assessment in SpondyloArthritis International Society (ASAS)20 response rate of 56.4%, while the placebo group reported only 29%. Based on the ASAS40 response, those who had the XELJANZ logged 40.6% versus the 12.5% from the placebo takers.
The safety and efficacy profiles for XELJANZ’s use in active AS were observed to be consistent with the responses observed in PsA and RA patients.
“This regulatory approval affirms the clinical value and versatility of XELJANZ, the first and only Janus kinase (JAK) inhibitor approved for five indications in the United States for the treatment of patients with certain immuno-inflammatory conditions,” commented Mike Gladstone, the global president of Pfizer’s inflammation and immunology division, in a statement.
Ankylosing spondylitis is a chronic inflammatory illness that manifests in early adulthood in both men and women. It affects over 350,000 people in the U.S. alone. Symptoms include chronic pain and back and hip stiffness, affecting one’s overall quality of life. Left unaddressed, some patients later experience vertebrae fusion in the spinal column.
The European Commission approved XELJANZ in November and gave it a Marketing Authorization to be used in the same indication. There are reportedly over a million people in the E.U. who are living with AS. Prior to that, in September, the FDA issued a Drug Safety Communication (DSC) for the product. XELJANZ has been studied in over 50 clinical trials worldwide since 2012.
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