Novartis AG has announced that the FDA has approved Cosentyx (secukinumab) for two new indications: the treatment of adults with active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA). The approvals come as the result two AS and two PsA placebo-controlled Phase III studies involving more than 1, 500 patients.
According to the January 15, 2016 news release, these new approvals makes Cosentyx the first and only interleukin-17A (IL-17A) antagonist approved for AS, as well as moderate to severe plaque psoriasis and PsA, which impacts as many as 30% of patients with psoriasis. Cosentyx was approved for adult patients with moderate to severe plaque psoriasis in January 2015 and more than 13, 000 patients with this disease in the U.S. have already been treated with Cosentyx.
“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, ” said Christi Shaw, U.S. Country Head, president at Novartis Corporation and Novartis Pharmaceuticals Corporation. “The approval of additional indications for Cosentyx represents an important milestone for AS and PsA patients, their caregivers, and their doctors.”
“Working directly with patients who have AS and PsA, I have seen firsthand the devastating impact the diseases can have, ” said Philip Mease, M.D., director of rheumatology research at Swedish Medical Center, clinical professor at the University of Washington School of Medicine in Seattle and an investigator in the Cosentyx clinical trial program. “I welcome the addition of Cosentyx as a new treatment option for my patients with AS and PsA.”
Cathryn M. Clary, M.D., head of U.S. Clinical Development & Medical Affairs for Novartis, told OTW, “The approval of Cosentyx provides physicians and appropriate adult patients with the first treatment for active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA) targeting the IL-17A pathway. Our studies show that many patients treated with Cosentyx have a significant reduction in their signs and symptoms, while offering a consistent safety profile across all indications including plaque psoriasis (PsO).”
“For patients with AS, the MEASURE 2 study showed that patients treated with 150 mg Cosentyx met the primary endpoint achieving statistically significant improvements versus placebo in the signs and symptoms of AS, as measured by at least a 20% improvement in the Assessment of Spondyloarthritis International Society criteria (ASAS20) at Week 16.”
“Since treatment options for patients with AS and PsA are limited, we’re delighted that the FDA approved Cosentyx for these additional indications just one year after the approval for moderate-to-severe psoriasis. These approvals provide an important new option for those suffering from these life-long, painful inflammatory diseases.”
