FDA approves Novartis’ Cosentyx to treat plaque psoriasis

Offering a new treatment option for psoriasis patients, Cosentyx is the first approved human monoclonal antibody (mAb) that selectively binds to interleukin IL-17A and inhibit interaction with the IL-17 receptor.

The FDA approval was based on the efficacy and safety outcomes from ten Phase II and Phase III trials, which included more than 3,990 adult patients with moderate-to-severe plaque psoriasis.

The trial showed that Cosentyx resulted in clear or almost clear skin in the majority of patients and had an acceptable safety profile.

Novartis Pharmaceuticals division head David Epstein said: "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.

"This important milestone will now allow patients to receive a treatment that has the proven ability to offer clear or almost clear skin."

The Phase III clinical program included four placebo-controlled trials which evaluated Cosentyx 300mg and 150mg in these patients.

Earlier this month, Cosentyx was also approved by the European Commission (EC) as a first-line systemic treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.

Image: Novartis headquarters in Basel Switzerland. Photo: courtesy of Andrew.