Novartis announced that the Food and Drug Administration (FDA) has approved Cosentyx (secukinumab) for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

Cosentyx is a human monoclonal antibody (mAb) that selectively binds to interleukin-17A (IL-17A) and inhibits its interaction with the IL-17 receptor. It is the first IL-17A inhibitor approved by the FDA with this indication.

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This approval was based on the safety and efficacy outcomes from 10 Phase 2 and 3 studies that included over 3,990 patients with moderate to severe plaque psoriasis. In the Phase 3 trials, all primary and key secondary endpoints were met including significant skin clearance at Week 12.

Cosentyx will be available as a 150mg/mL solution in a single-use Sensoready pen, a 150mg/mL solution in a single-use prefilled syringe, and a 150mg lyophilized powder in a single-use vial for reconstitution.

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