EU approves Cosentyx (secukinumab) to treat Plaque Psoriasis- Novartis

Novartis has announced that the European Commission (EC) has approved Cosentyx (secukinumab, formerly known as AIN 457) 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 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 Cosentyx 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 Cosentyx was superior to Stelara in clearing skin of patients living with moderate-to-severe Plaque Ppsoriasis. 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. 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.

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 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.

Comment: Further down the line are coming brodalumab, an interleukin-17 (IL-17) receptor inhibitor, from Amgen/AstraZeneca now in Phase III trials. Its unique action appears effective according to data from the AMAGINE-1 study. Ixekizumab, an anti-IL-17 monoclonal antibody, from Eli Lilly also targets IL-17 and now in the Phase III UNCOVER studies has shown itself superior to Enbrel.