EC Approves Novartis Psoriasis Drug
Novartis has received approval from the European Commission (EC) for Cosentyx (secukinumab) as a first-line systemic* treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.
Cosentyx is an interleukin-17A (IL-17A) inhibitor and it provides a 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. Cosentyx is a human monoclonal antibody that selectively neutralizes IL-17A. IL-17A is found in high concentrations in skin affected by psoriasis and is a preferred target for investigational therapies. Cosentyx works by inhibiting the action of interleukin-17A (IL-17A), a protein found in high concentrations in skin affected by the disease.
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.
The US Food and Drug Administration (FDA) decision in moderate-to-severe plaque psoriasis is anticipated early in 2015 following the recommendation of approval in October 2014 from the Dermatologic and Ophthalmic Drugs Advisory Committee to the US FDA.
Cosentyx is also in Phase III development for psoriatic arthritis (PsA) and ankylosing spondylitis (AS); regulatory applications are planned for 2015.
Source: Novartis