Swiss drug-maker Novartis has obtained approval from US Food and Drug Administration for its Cosentyx (secukinumab) to treat moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy.
Cosentyx, formerly known as AIN457, is a human monoclonal antibody (mAb) that selectively inhibits interleukin-17A (IL-17A), which is observed in high concentrations in skin affected by psoriasis.
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."
Approval was based on the efficacy of ten Phase II and Phase III studies, which included 3,990 adult patients with moderate-to-severe plaque psoriasis.
According to the company, studies demonstrated that Cosentyx resulted in clear or almost clear skin in the majority of patients and had an acceptable safety profile.
The Phase III clinical programme comprised four placebo-controlled studies, which assessed Cosentyx 300mg and 150mg in patients with moderate-to-severe plaque psoriasis.
The trials met all primary and key secondary endpoints, including Psoriasis Area and Severity Index (PASI) 75 and 90, and Investigator’s Global Assessment modified 2011 (IGA) 0/1 responses, showing significant skin clearance at week 12, noted Novartis.
Novartis received approval from European Commission (EC) for Cosentyx to treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.
Cosentyx was also approved in Australia to treat moderate-to-severe plaque psoriasis, and in Japan to treat moderate-to-severe plaque psoriasis and active psoriatic arthritis (PsA).
Image: Novartis AG headquarters in Basel. Photo: courtesy of Andrew.