The US Food and Drug Administration (FDA) has approved Novartis’ Cosentyx (secukinumab) for the treatment of adult patients with active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA)
AS and PsA are both 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.
Cosentyx was FDA approved for adult patients with moderate to severe plaque psoriasis in January 2015 and more than 13,000 patients with this disease in the US have already been treated with the drug, according to Novartis.
Christi Shaw, US country head, president at Novartis Corporation and Novartis Pharmaceuticals Corporation, said: "We were inspired by patients to pursue new indications for AS and PsA, because these diseases can result in significant pain and impede the simplest of tasks in a person's daily life.
"The approval of additional indications for Cosentyx represents an important milestone for AS and PsA patients, their caregivers, and their doctors."
The approvals are based on the efficacy and safety outcomes from two AS and two PsA placebo-controlled phase three studies which included more than 1,500 adult patients with either AS or PsA.
Novartis said that in the studies, Cosentyx met the primary endpoints achieving statistically significant improvements versus placebo in the signs and symptoms of AS and PsA.