Novartis' Cosentyx For Plaque Psoriasis Backed By CHMP

Novartis announced that it has received a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for Cosentyx (secukinumab) as first-line systemic therapy for the treatment of moderate-to-severe plaque psoriasis in adults in the EU.

Secukinumab is a first-in-class selective interleukin-17A (IL-17A) inhibitor that works to stop the release of pro-inflammatory cytokines. Aside from plaque psoriasis, Novartis is also developing secukinumab in late-stage trials for psoriatic arthritis (PsA) and ankylosing spondylitis (AS).

“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. With this exciting news, we may change the way psoriasis is treated, as 50 percent 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,” said David Epstein, Division Head of Novartis Pharmaceuticals.

The recommendation follows that of its U.S. counterpart, the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the U.S. Food and Drug Administration. The Committee also said it votes for the approval of Cosentyx as treatment for moderate-to-severe plaque psoriasis. Positive data from the Phase 3 clinical trial program for secukinumab supported both recommendations. In the trials, secukinumab was able to consistently demonstrate very high skin clearance and superiority to comparator drug Enbrel (etanercept) by Amgen. Secukinumab also had a favorable safety profile.

The European Commission usually follows the CHMP opinions, though it is free to make its own decision. The final decision of the EU regulatory office is expected within approximately 2 months of the release of the CHMP opinion.

According to six analyst estimates compiled by Bloomberg, Cosentyx is poised to bring in $1.1 billion in sales for Novartis in 2020. Plaque psoriasis affects over 125 million worldwide.