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Novartis gets EU nod for psoriasis biologic drug

20 January 2015 | News | By BioSpectrum Bureau

Novartis gets EU nod for psoriasis biologic drug

Cosentyx is a human monoclonal antibody for psoriasis

Cosentyx is a human monoclonal antibody for psoriasis

Singapore: Global pharmaceutical company, Novartis, has recieved European Commission (EC) nod for Cosentyx (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.

"With this groundbreaking news from the European Commission, clear skin may now be a reality for patients living with psoriasis," said David Epstein, Division Head, Novartis Pharmaceuticals. "Nearly half of psoriasis patients are not content with current therapies, including biologic treatments, showing a significant unmet need for patients. Cosentyx, with a first-line systemic indication for treatment of psoriasis will provide patients a better chance of achieving clear or almost clear skin."

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.

Cosentyx is a human monoclonal antibody that selectively neutralizes IL-17A, found in high concentrations in skin affected by psoriasis and is a preferred target for investigational therapies.

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