The European Commission ( EC ) has approved Cosentyx ( Secukinumab ) 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.
The key treatment goal for psoriasis patients is achieving clear skin. In clinical studies, 70% or more Secukinumab 300 mg patients achieved clear skin ( PASI 100 ) or almost clear skin ( 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.
Data from the Cosentyx clinical trial program also showed a significant positive relationship between achieving clear to almost clear skin and psoriasis patients' health-related quality of life.
The EU approval follows the recent results of the phase IIIb CLEAR study, which showed that Secukinumab was superior to Ustekinumab in clearing skin of patients living with moderate-to-severe plaque psoriasis.
The CLEAR study was the second head-to-head study for Secukinumab.
Secukinumab also showed superiority to Etanercept ( Enbrel ) in clearing skin in the FIXTURE study.
In the phase III clinical program the overall safety profile of Secukinumab was favorable, with minimal differences seen between Etanercept and Ustekinumab in head-to-head comparison.
Secukinumab, a human monoclonal antibody, works by inhibiting the action of interleukin-17A, a protein found in high concentrations in skin affected by the disease.
Psoriasis is a chronic immune-mediated disease characterized by thick and extensive skin lesions, called plaques, known to cause itching, scaling and pain; it is associated with significant impairment of physical and psychological quality of life.
Psoriasis affects up to 3% of the world's population, or more than 125 million people.
In Europe, the estimate is about 0.8%, which means that plaque psoriasis affects about 3.7 million Europeans, with about 2.4 million considered to have moderate-to-severe disease. ( Xagena )
Source: Novartis, 2015