15 January 2016 - FDA approval for Cosentyx is based on efficacy and safety outcomes shown across four Phase III studies, including over 1,500 patients with either AS or PsA.
Novartis announced today that the US 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.
Cosentyx is the first in a new class of medicines called interleukin-17A inhibitors to treat both AS and PsA. The two new indications follow the earlier FDA approval for Cosentyx in January 2015 to treat adult patients with moderate-to-severe plaque psoriasis, and European approval for AS and PsA in November 2015.