FDA approves secukinumab for treatment of AS and PsA

The FDA has approved secukinumab for the treatment of adult patients with ankylosing spondylitis and psoriatic arthritis, Novartis announced in a press release.

Secukinumab (Cosentyx, Novartis) is an interleukin-17A inhibitor, and reportedly is the first of its kind to meet approval by the FDA for the treatment of ankylosing spondylitis (AS) and psoriatic arthritis (PsA).

“We were inspired by patients to pursue new indications for AS and PsA, because these diseases can result in significant pain and impede the simplest of tasks in a person’s daily life,” Christi Shaw, U.S. country head and president at Novartis Corp. and Novartis Pharmaceuticals Corp., said in the press release. “The approval of additional indications for Cosentyx represents an important milestone for AS and PsA patients, their caregivers, and their doctors.”

The approval follows four phase 3 studies with more than 1,500 patients with either AS or PsA. The primary endpoint of at least a 20% reduction of disease activity was met in the studies compared to placebo.

“Working directly with patients who have AS and PsA, I have seen firsthand the devastating impact the diseases can have,” Philip Mease, MD, director of rheumatology research at Swedish Medical Center, clinical professor at the University of Washington School of Medicine in Seattle and an investigator in the Cosentyx clinical trial program, said in the press release. “I welcome the addition of Cosentyx as a new treatment option for my patients with AS and PsA.”

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