FDA approves Cosentyx (secukinumab) for treatment of ankylosing spondylitis and psoriatic arthritis- Novartis

Novartis has announced that the FDA has approved Cosentyx (secukinumab) for the treatment of two new indications - adults with active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA). AS and PsA are both life-long, painful and debilitating inflammatory diseases that affect the joints and/or spine. If not treated effectively, both conditions can lead to irreversible joint and/or spinal bone damage caused by years of inflammation.

The approvals are based on the efficacy and safety outcomes from four placebo-controlled Phase III studies, which included over 1,500 adult patients with AS or PsA that were biologic treatment naïve or had an inadequate response / were intolerant to anti-TNFs. In the studies, 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 (ASAS 20) at Week 16, and a 20% reduction in the American College of Rheumatology (ACR 20) response criteria at Week 24, respectively. ASAS 20 and ACR 20 are standard tools used to assess clinical improvement in AS and PsA.

Comment: Cosentyx is approved for the treatment of AS and PsA in the European Union, Ecuador and Bangladesh, and for the treatment of PsA in Japan.