Two New FDA Approvals for Secukinumab (Cosentyx)

First IL-17A inhibitor approved for adults with ankylosing spondylitis or psoriatic arthritis

The FDA has approved secukinumab (Cosentyx, Novartis) for the treatment of adults with two new indications: active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA). AS and PsA are life-long painful and debilitating inflammatory diseases that affect the joints and/or spine. If not treated effectively, both conditions can lead to irreversible joint and/or spinal bone damage caused by years of inflammation.

Secukinumab is the first in a new class of interleukin-17A inhibitors to treat both AS and PsA. The new indications follow the FDA’s approval of secukinumab in January 2015 to treat adult patients with moderate-to-severe plaque psoriasis.

The new approvals were based on efficacy and safety outcomes from four placebo-controlled phase 3 studies, which included more than 1,500 adults with AS or PsA who were naïve to biologic treatment or who had shown an inadequate response to or were intolerant of anti-tumor necrosis factor (TNF) therapies. Secukinumab met the primary endpoints in these studies, achieving statistically significant improvements compared with placebo in the signs and symptoms of AS and PsA, as measured by at least a 20% improvement in the Assessment of Spondyloarthritis International Society criteria (ASAS 20) at week 16, and a 20% reduction in the American College of Rheumatology (ACR 20) response criteria at week 24, respectively.

AS is caused by spinal inflammation, which can result in irreversible damage. Up to 70% of patients who develop severe AS will experience spinal fusions over 10 to 15 years, which can significantly reduce mobility. People 25 years of age or older, particularly men, are affected most often. Approximately 20% to 40% of patients do not respond well to standard-of-care biologic medications, and few therapeutic options are available.

PsA is an inflammatory condition of the joints and is often associated with psoriasis. The symptoms of PsA include joint pain and stiffness, skin and nail psoriasis, swollen toes and fingers, and persistent painful enthesitis. Up to 40% of patients may experience joint destruction and permanent physical deformity. As many as 30% of patients with psoriasis have PsA. Many patients do not respond to or are tolerant of current therapies, and approximately 45% of PsA patients are dissatisfied with treatments.

Source: Novartis; January 15, 2016.