FDA Approves Orencia for Psoriatic Arthritis

The U.S. Food and Drug Administration has approved Orencia for the treatment of patients with active psoriatic arthritis. It is approved for both subcutaneous and intravenous injections, according to a company press release.

It is currently used to treat rheumatoid arthritis and juvenile idiopathic arthritis.

“This approval underscores the efficacy of Orencia in adult patients with active psoriatic arthritis, who have been in need of new treatments,” said Brian J. Gavin, a vice president at Bristol-Myers Squibb, in a press release. “Helping to advance clinical understanding of autoimmune conditions is a key focus of our immunoscience research, and we’re proud to introduce Orencia, a selective T-cell co-stimulation modulator, as an additional treatment option for PsA.”

The approval was based on results from two randomized, double-blind, placebo-controlled trials in which Orencia improved (or reduced) disease activity in both TNF-naive and exposed patients with high disease activity, high tender and swollen joints, and a disease duration of more than seven years.

Psoriatic arthritis can cause joint pain, stiffness and reduced range of motion, potentially affecting the ability to do everyday activities, such as getting dressed and tying shoes. In PsA, the immune system attacks healthy joints and skin.

“Psoriatic arthritis takes a toll on patients and families over time,” said Randy Beranek, president and CEO, National Psoriasis Foundation. “We welcome the introduction of an additional treatment option for adults with active psoriatic arthritis, because we believe advancements, along with further research, education and support services, are critical to helping improve the lives of those impacted.”

“It can be difficult to treat active psoriatic arthritis patients because the disease course is unpredictable, and patients are often treated with a variety of medications such as classic DMARDs and TNFs over time. Furthermore, once they have been treated, it may be more difficult to obtain an adequate efficacy response,” said Philip Mease, M.D., Clinical Professor at the University of Washington School of Medicine and Director of the Rheumatology Clinical Research Division of Swedish Medical Center. “The data that formed the basis of this approval demonstrate that Orencia offers an additional treatment option for patients with active psoriatic arthritis who have already tried a TNF inhibitor, as well as those who have not.”

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