FDA Approves Novartis’ Cosentyx

FDA has approved Novartis’ Cosentyx (secukinumab) to treat active psoriatic arthritis in patients age 2 and older and for active enthesitis-related arthritis in those age 4 and older. The company says Cosentyx is the first biologic indicated for enthesitis-related arthritis and the only biologic agent approved for both enthesitis-related arthritis and juvenile psoriatic arthritis in the U.S.

In the Phase 3 JUNIPERA study, juvenile patients with active psoriatic arthritis who received Cosentyx demonstrated a significantly longer time to flare, compared with placebo. Patients with active enthesitis-related arthritis who were treated with the drug also had a longer time to flare. Novartis says safety findings were consistent with the drug’s known profile in treating plaque psoriasis, psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis.