FDA Approves Novartis' Psoriasis Drug Cosentyx

By RTT News, January 21, 2015, 08:42:00 PM EDT

(RTTNews.com) - Novartis AG ( NVS ) announced the US Food and Drug Administration has approved Cosentyx (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy, a drug that is absorbed into the bloodstream and distributed to all parts of the body, or phototherapy (light therapy).

Cosentyx is the first approved psoriasis medication to selectively bind to IL-17A and inhibit interaction with the IL-17 receptor.

The approval is based on the efficacy and safety outcomes from 10 Phase II and Phase III studies, including over 3,990 adult patients with moderate-to-severe plaque psoriasis, which demonstrated that Cosentyx resulted in clear or almost clear skin in the majority of patients and had an acceptable safety profile.

The FDA approval follows the unanimous vote by the FDA Advisory Committee in October 2014. Additionally, in January 2015, the European Commission (EC) approved Cosentyx as a first-line systemic treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.

In addition to the US, Cosentyx has been approved in the EU and Australia for the treatment of moderate-to-severe plaque psoriasis and in Japan for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis (PsA).

In addition to psoriasis, Cosentyx is also in clinical trials for the treatment of PsA and ankylosing spondylitis (AS). Global regulatory applications for secukinumab in AS and PsA are planned for 2015.

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FDA Approves Novartis' Psoriasis Drug Cosentyx