FDA approves Cosentyx for two new indications

The US Food and Drug Administration (FDA) has approved Cosentyx® (secukinumab) for the treatment of two new indications – adults with active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA).

Cosentyx is the first in a new class of medicines called interleukin-17A (IL-17A) inhibitors to treat both AS and PsA. The two new indications follow the earlier FAD approval for Cosentyx in January 2015 to treat adult patients with moderate-to-sever plaque psoriasis, and European approval for AS and PsA in November of the same year.

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 – or were intolerant to – anti-TNFs.

More than 9,600 patients have been treated with Cosentyx in clinical trials across multiple indications, and over 15,000 patients with psoriasis have already been treated in the post-marketing setting. The safety profile of Cosentyx was shown to be consistent with that seen in clinical trials across multiple indications.

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 join and/or spinal damage caused by years of inflammation. In the US, it is estimated that up to 0.5 per cent of the population has AS, and up to 1 per cent live with PsA.


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