Novartis Cosentyx(TM) receives positive CHMP opinion for first-line treatment of moderate-to-severe psoriasis patients

Novartis International AG / Novartis Cosentyx(TM) receives positive CHMP opinion for first-line treatment of moderate-to-severe psoriasis patients . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• Cosentyx (secukinumab, formerly AIN457) is recommended as first-line systemic therapy for the treatment of moderate-to-severe plaque psoriasis in adult patients in Europe

• In Phase III studies, 70% or more patients achieved clear skin (PASI 100) or almost clear skin (PASI 90) with secukinumab 300 mg during the first 16 weeks of treatment[1]

• Clinical trials consistently showed very high skin clearance, sustained efficacy and a favorable safety profile for secukinumab[1]-[3]

The digital press release with multimedia content can be accessed here:

 

Basel, November 21, 2014 - Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of 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.

This recommendation would mean doctors could use secukinumab first-line to treat their psoriasis patients, as an alternative to other first-line systemic treatments, which have significant side effects[4]. Currently, all biologic treatments for psoriasis, including anti- tumor necrosis factor therapies (anti-TNFs) and ustekinumab are recommended for second-line systemic therapy in Europe[5]-[7].

Secukinumab (at a dose of 300 mg) is the first interleukin-17A (IL-17A) inhibitor to be recommended as a first-line treatment option for psoriasis patients who require systemic therapy in Europe. Secukinumab works by inhibiting the action of IL-17A, a protein that is found in high concentrations in skin affected by the disease[8]-[13].

"This positive CHMP opinion for secukinumab as a first-line treatment of psoriasis brings us one step closer to approval in Europe and making clear skin a reality for psoriasis patients," said David Epstein, Division Head, Novartis Pharmaceuticals. "With this exciting news, we may change the way psoriasis is treated, as 50% of patients are unhappy with their current psoriasis therapies, demonstrating an urgent need for new treatments that clear skin faster and for a longer time."