FDA approves Pfizer’s tofacitinib for ankylosing spondylitis

Pfizer (NYSE:PFE) has received FDA approval for the supplemental New Drug Application (sNDA) for Xeljanz/Xeljanz XR (tofacitinib) as a treatment of adults with active ankylosing spondylitis (AS).

About 350,000 Americans have the condition.

The Xeljanz approval covers patients who had an insufficient response or intolerance to one or more tumor necrosis factor (TNF) blockers.

Xeljanz is a Janus kinase (JAK) inhibitor and the first to find approval for five indications in the U.S., noted Mike Gladstone, global president, inflammation and immunology, Pfizer, in a press release.

To win approval, Pfizer submitted data from a Phase 3, multicenter, randomized, double-blind, placebo-controlled study.

With this approval, physicians and patients now have an additional oral treatment option that can help address this chronic and often progressive disease,” said Steven Taylor, executive vice president, mission and strategic initiatives of the Arthriti…

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AbbVie’s Rinvoq met primary endpoint in ankylosing spondylitis trial 

AbbVie (NYSE:ABBV) has announced positive top-line results in a Phase 3 trial focusing on patients with active ankylosing spondylitis (AS), an inflammatory disease that can eventually lead to fused vertebrae.

The first of two studies, the SELECT-AXIS 2 study examined a daily 15-mg dose of Rinvoq (upadacitinib) in AS patients who had an inadequate response to biologic disease-modifying antirheumatic drugs (bDMARD) therapy.

Rinvoq is a Janus kinase (JAK) inhibitor presently FDA indicated for moderately to severely active rheumatoid arthritis patients. The FDA indication specifically covers patients with a prior history of inadequate response or intolerance to the immunosuppressive drug methotrexate.

The study used the Assessment in SpondyloArthritis International Society (ASAS) 40 response by week 14 as a primary endpoint.

A total of 45% of Rinvoq recipients achieved an ASAS40 score at week 14 compared to 18% of placebo recipients. Similarly, 44% of…

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