FDA Approves Novartis’ Cosentyx for Plaque Psoriasis

Novartis announced on Jan. 21, 2015 that FDA approved its drug Cosentyx (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. An FDA advisory panel voted unanimously in favor of the drug in October 2014, and the European Commission (EC) approved Cosentyx in January 2015 as a first-line systemic treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.

In the FIXTURE study, conducted in 2013, Novartis concluded that secukinumab demonstrated “significantly superior” efficacy over Enbrel (etanercept), which is considered to be the current standard of care and is the most commonly used drug among TNF inhibitors to treat psoriasis. The drug's efficacy was also tested in three other Phase III trials: the ERASURE, FEATURE, and JUNCTURE studies.

The apparent clinical superiority of Cosentyx in achieving skin clearance compared with standard efficacy measures relies on its mechanism of action. Cosentyx targets and neutralizes the function of proinflammatory cytokine IL-17A-a messenger protein typically found in high concentrations in psoriasis skin plaques.

"The FDA's approval of Cosentyx signifies a turning point for psoriasis patients, who can now benefit from the first and only approved treatment targeting the IL-17 pathway, which is proven to play a key role in the development of plaque psoriasis," said David Epstein, division head, Novartis Pharmaceuticals, in a press release. "This important milestone will now allow patients to receive a treatment that has the proven ability to offer clear or almost clear skin.”

Cosentyx's competitors will include Eli Lilly's IL-17 inhibitor ixekizumab, which demonstrated superiority over Enbrel as well. Ixekizumab has an expected approval date in the first half of 2015. And Amgen/AstraZeneca's brodalumab, which bested Johnson & Johnson's Stelara (ustekinumab) in a head-to-head clinical trial, is likely to gain approval in 2015.

Source: MarketWatch