Novartis' Cosentyx Approved By EU For First-line Systemic Treatment Of Psoriasis

By RTT News, January 19, 2015, 02:05:00 AM EDT

(RTTNews.com) - Swiss drugmaker Novartis AG ( NVS ) announced that the European Commission or EC has approved Cosentyx (TM) as a first-line systemic treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.

Cosentyx is the first and only biologic that has been approved in Europe as first-line systemic therapy in the treatment of psoriasis and as an alternative to treatments that have significant side effects. All other biologic treatments for psoriasis, including anti-tumor necrosis factor therapies and Stelara are recommended for second-line systemic therapy in Europe, according to the company.

The company said that the key treatment goal for psoriasis patients is achieving clear skin. In clinical studies, 70% or more Cosentyx 300 mg patients achieved clear skin or PASI 100 or almost clear skin or PASI 90, during the first 16 weeks of treatment and importantly, this was maintained with continued treatment in the majority of patients up to Week 52.

Novartis stated that the EU approval follows the recent results of the Phase IIIb CLEAR study, which showed that Cosentyx was superior to Stelara in clearing skin of patients living with moderate-to-severe plaque psoriasis. The CLEAR study was the second head-to-head study for Cosentyx. Cosentyx also showed superiority to Enbrel in clearing skin in the FIXTURE study.

In addition to the EU, Cosentyx has been approved in 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.

Further, the company said that the US Food and Drug Administration or FDA decision in moderate-to-severe plaque psoriasis is anticipated early in 2015 following the unanimous recommendation of approval in October 2014 from the Dermatologic and Ophthalmic Drugs Advisory Committee or DODAC to the US FDA.

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Novartis' Cosentyx Approved By EU For First-line Systemic Treatment Of Psoriasis