Cosentyx Gets Radiographic Protection Indication for Psoriatic Arthritis Save

Novartis announced today that the US Food and Drug Administration (FDA) approved the inclusion of new evidence that Cosentyx® (secukinumab) significantly slows the progression of joint structural damage at Week 24 versus placebo in those with active psoriatic arthritis (PsA).

The data will be added to the drug’s prescribing information. Cosentyx is the first interleukin-17A (IL-17A) antagonist approved to treat active PsA, active ankylosing spondylitis, and moderate to severe plaque psoriasis in adults.  More than 74,000 patients in the US have been prescribed Cosentyx in the post-marketing setting across all indications since launch.

PsA affects an estimated 2 million people in the US and can lead to irreversible joint damage and disability caused by years of inflammation.

Cosentyx is a fully human monoclonal antibody (mAB) that selectively binds to the interleukin-17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor.1

The FUTURE 5 study included 996 active psoriatic arthritis (PsA) randomized to receive secukinumab 300 mg with loading dose (LD), 150 mg with LD, 150 mg without LD, or placebo. At Week 16, placebo non-responders were switched to SEC 300 mg or 150 mg; remaining placebo patients were switched at Week 24. The percentage of patients with no disease progression (defined as a change from baseline in mTSS of less than or equal to 0.0) from randomization to Week 24 was 75.7%, 70.9%, and 76.5% for Cosentyx 150 mg without load, 150 mg, 300 mg, respectively versus 68.2% for placebo.