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Novartis’ Cosentyx Wins Two New Approvals

January 18, 2016

Gains new indications for active ankylosing spondylitis and active psoriatic arthritis

Novartis’ Cosentyx (secukinumab) has been approved by the FDA for two new indications, active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA). Both are life-long, painful and debilitating inflammatory diseases that affect the joints and/or spine.  

Cosentyx is now the first and only interleukin-17A (IL-17A) antagonist approved for AS, as well as moderate to severe plaque psoriasis and PsA, which impacts as many as 30% of patients with psoriasis. Cosentyx was approved for moderate to severe plaque psoriasis in January 2015.

The approvals are based on two AS and two PsA placebo-controlled Phase III studies in more than 1,500 adult patients with either AS or PsA. Cosentyx met the primary endpoints achieving statistically significant improvements versus placebo in the signs and symptoms of AS and PsA, as measured by at least a 20% improvement in the Assessment of Spondyloarthritis International Society criteria (ASAS20) and a 20% reduction in the American College of Rheumatology (ACR20) response criteria.
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