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FDA Approves Cosentyx (secukinumab) for Treatment of Adult Patients With AS and PsA


January 18, 2016

The FDA has approved a new drug, Cosentyx (secukinumab) manufactured by Novartis, to treat adult patients with active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA).

Approval was based on the efficacy and safety outcomes from 2 AS and 2 PsA placebo-controlled Phase III studies including more than 1,500 adult patients with either AS or PsA. Secukinumab achieved statistically significant improvement versus placebo in the signs and symptoms of AS and PsA.

Because secukinumabis affects the immune system, patients may have a greater risk of getting an infection. Caution should be used when prescribing secukinumabis to patients with a chronic infection or a history of recurrent infection, and in patients with active Crohn’s Diseas.

The most commonly reported side effects are diarrhea and upper respiratory infections.

Secukinumab is the first interleukin-17A (IL-17A) antagonist approved for AS, as well as moderate to severe plaque psoriasis and PsA. Secukinumab was approved for adult patients with moderate to severe plaque psoriasis in January 2015.

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