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Basel, 19 January 2015 - Novartis announced today that the European Commission (EC) has approved Cosentyx(TM) (secukinumab, formerly known as AIN457) as a first-line systemic* treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.
Cosentyx (at a dose of 300 mg) is the first and only interleukin-17A (IL-17A) inhibitor to be approved in Europe and this approval marks a significant milestone in the treatment of psoriasis, providing a new and important first-line biologic treatment option for patients. Currently, all biologic treatments for psoriasis, including anti-tumor necrosis factor therapies (anti-TNFs) and Stelara®** (ustekinumab) are recommended for second-line systemic therapy in Europe[2-4].
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®*** (etanercept) in clearing skin in the FIXTURE study[6]. In the Phase III clinical program the overall safety profile of Cosentyx was favorable, with minimal differences seen between etanercept and ustekinumab in head-to-head comparison[5,6].
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 (PsA).
The US Food and Drug Administration (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 (DODAC) to the US FDA.
Via Krishan Maggon
Cosentyx showed superiority to Stelara® in the Phase IIIb CLEAR study[5]
In Phase III studies, 70% or more Cosentyx 300 mg patients achieved clear skin (PASI 100) or almost clear skin (PASI 90) during the first 16 weeks of treatment[6]
Achieving clear skin is the ultimate treatment goal for patients with psoriasis; 50% of psoriasis patients are not content with current therapies[7-10] Cosentyx is a human monoclonal antibody that selectively neutralizes IL-17A[12,13]. IL-17A is found in high concentrations in skin affected by psoriasis and is a preferred target for investigational therapies[12-17]. Cosentyx works by inhibiting the action of interleukin-17A (IL-17A), a protein found in high concentrations in skin affected by the disease[12-17]. In the Phase III program, Cosentyx demonstrated a favorable safety profile, with similar incidence and severity of adverse events between secukinumab treatment arms (300 mg and 150 mg)[5,18-20].
Cosentyx showed superiority to Stelara® in the Phase IIIb CLEAR study[5]
In Phase III studies, 70% or more Cosentyx 300 mg patients achieved clear skin (PASI 100) or almost clear skin (PASI 90) during the first 16 weeks of treatment[6]
Achieving clear skin is the ultimate treatment goal for patients with psoriasis; 50% of psoriasis patients are not content with current therapies[7-10]