Novartis announced that the Food and Drug Administration (FDA) has approved Cosentyx (secukinumab) for the treatment of adults with active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA). Cosentyx is the first IL-17A antagonist approved for adults with active AS and PsA.

The FDA approvals were supported by efficacy and safety outcomes from 2 AS and 2 PsA Phase 3 multi-center, randomized, placebo-controlled studies that included over 1,500 adults with either AS or PsA. Cosentyx met the primary endpoints of achieving statistically significant improvements vs. placebo in the signs and symptoms of AS and PsA, as measured by ≥20% improvement in the ASAS20 at Week 16, and a 20% reduction in the ACR20 response criteria at Week 24.

RELATED: Cosentyx Efficacious in Psoriatic Arthritis Study

Cosentyx was approved for the treatment of adults with moderate to severe plaque psoriasis in January 2015. It is a human IgG1 monoclonal antibody that selectively binds to the interleukin-17A cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Secukinumab inhibits the release of proinflammatory cytokines and chemokines.

Cosentyx is available as a 150mg/mL Sensoready pen in 1- and 2-count cartons, and as a 150mg/mL prefilled syringe in 1- and 2-count cartons. It is also available as a 150mg strength lyophilized powder in a single-use vial.

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