FDA approvals for Cosentyx for ankylosing spondylitis and psoriatic arthritis

Novartis announced today that the US Food and Drug Administration (FDA) has approved Cosentyx^®(secukinumab) for two new indications – 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.^2,3,4

With these new approvals, Cosentyx is now 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.⁵ 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 US 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, US 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.”

The approvals are based on the efficacy and safety outcomes from two AS and two PsA placebo-controlled Phase III studies which included more than 1,500 adult patients with either AS or PsA. In the studies, Cosentyx met the primary endpoints achieving statistically significant improvements versus 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 (ASAS20) at Week 16 and a 20% reduction in the American College of Rheumatology (ACR20) response criteria at Week 24, respectively.¹ ASAS20 and ACR20 are standard tools used to assess clinical improvement in AS and PsA. The safety profile is consistent across the three approved indications.¹

“Working directly with patients who have AS and PsA, I have seen firsthand the devastating impact the diseases can have,” said Philip Mease, MD, 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.”

About ankylosing spondylitis (AS)

• Ankylosing spondylitis (AS) is a painful and often progressively debilitating disease, caused by spine inflammation that can result in irreversible damage.⁶
• Up to 70% of patients who go on to develop severe AS will form spinal fusions (where the bones grow together) over 10 to 15 years, which significantly reduces mobility.⁷
• In the United States, the prevalence of AS is estimated to be between 0.2% and 0.5%, with nearly half a million people affected.^8,9
• Males are affected most often and family members of those with AS are at higher risk.¹⁰
• Approximately 20-40% of patients do not respond well to standard of care biologic medicines, and there are few therapeutic options available to those patients.¹¹

About psoriatic arthritis (PsA)

• Between 0.3% and 1% of the general population may be affected by psoriatic arthritis (PsA) and up to 15% of people with psoriasis may have undiagnosed PsA.^12,13
• Symptoms of PsA include joint pain and stiffness, skin and nail psoriasis, swollen toes and fingers and persistent painful ethesitis (inflammation of the sites where tendons or ligaments insert into the bone).³
• PsA can lead to irreversible joint damage and disability caused by years of inflammation.³
• Up to 40% of people can suffer from joint destruction and permanent physical deformity.¹⁴
• New medicines are needed as many patients do not respond to, or tolerate current therapies and approximately 45% of PsA patients are dissatisfied with treatments.¹⁵

About Cosentyx AS and PsA clinical trial programsPivotal Phase III studies in the Cosentyx clinical trial program that provided key data for the submission were MEASURE 1 and MEASURE 2 involving 590 patients with AS, and FUTURE 1 and FUTURE 2 including 1,003 patients with PsA. Data from these pivotal trials were published in The New England Journal of Medicine and The Lancet. These are multi-center, randomized, placebo-controlled studies designed to evaluate the efficacy and safety of Cosentyx in AS and PsA.^16,17,18 Additional follow-up of patients from these trials is still ongoing.