Orencia now approved in three autoimmune diseases.

Bristol-Myers Squibb (BMS) has announced that FDA has approved Orencia for the treatment of adults with active psoriatic arthritis (PsA), a chronic, inflammatory disease that can affect both the skin and musculoskeletal system. Orencia is approved and available in both intravenous and subcutaneous (SC) injection formulations. This approval marks the third autoimmune disease indication for Orencia.

"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, Vice President, Orencia Development Lead at BMS. "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 co-stimulation blockade of Orencia inhibits T-cell activation and the resulting cascade of events that contribute to inflammation. T-cell activation is involved in the pathogenesis of PsA.

PsA 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.

"PsA 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 affected."

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 7 years.