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Bristol-Myers Squibb’s anti-arthritis drug wins FDA approval

Marian Chu  기사승인 2017.07.07  09:59:37

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Bristol-Myers Squibb said Thursday the U.S. Food and Drug Administration had approved Orencia for adults with Active Psoriatic Arthritis (PsA), a chronic, inflammatory disease that affects both the skin and musculoskeletal system.

PsA is a form of arthritis that causes joint inflammation due to an overactive immune system. It mostly affects people with psoriasis, a skin disease that features red patches of skin topped with silvery scales, according to Mayo Clinic. The U.S. National Institutes of Health estimates the direct health care costs for PsA to be as high as $1.9 billion annually in the United States.

“Psoriatic Arthritis takes a toll on patients and families over time,” said Randy Beranek, president, and CEO of the 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.”

Orencia (ingredient: abatacept) is available as both intravenous and subcutaneous injections. The drug was approved based on results from two randomized, double-blind, placebo-controlled trials. Orencia reduced disease activity in patients with high disease activity, high tender, and swollen joints, and a disease duration of more than seven years.

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

yjc@docdocdoc.co.kr

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