Novartis International AG recently announced that Cosentyx® has received FDA approval for the treatment of non-radiographic axial spondyloarthritis (nr-axSpA). Non-radiographic axial spondyloarthritis is a condition on the axial spondylarthritis disease spectrum that causes inflammatory arthritis and back pain without radiographic evidence of damage. An estimated 2.7 million Americans are believed to be on the disease spectrum. Ankylosing spondylitis is thought to be a more severe presentation of the disease on the same spectrum.
Cosentyx is a monoclonal antibody that targets interleukin-17A (IL-17a), a cytokine involved in the inflammation pathway. The drug was originally approved in 2015 to treat plaque psoriasis. It was then approved to treat psoriatic arthritis and ankylosing spondylitis in 2016.
The current approval marks the 4th indication for the drug. The approval came after completion of the PRECENT Phase III study of 555 adults suffering from nr-axSpA. Patients in the study achieved 40% improvement in a disease specific survey, the Assessment of Spondylarthritis International Society (ASA40), at one year. After 16 weeks, patients receiving Cosentyx had significantly greater improvement in the physical and mental components of the SF-36 questionnaire. No new safety concerns were raised by the study.
The FDA approval comes shortly after the European Medical Agency also approved the drug for the same indication. “There is a need for additional treatment options. Having a new treatment option for the axSpA community is truly encouraging,” said Cassie Shafer, CEO of the Spondylitis Association of America (SAA). “Helping reduce the burden on people living with non-radiographic axial spondyloarthritis by improving symptoms that affect their daily lives remains a critical focus for the SAA.”
The PREVENT study is expected to continue tracking efficacy for a second year, with an optional extension for an additional two years with randomized dose escalation treatment period. Clinicaltrials.gov lists 140 studies of Cosentyx for treatment of an array of autoimmune diseases in multiple patient populations with 46 currently underway.
