Secukinumab improved peripheral joint disease, prevented joint damage, and produced clear or almost clear skin in a pair of pivotal Phase 3 trials.
The investigational psoriatic arthritis (PsA) treatment known as secukinumab improved peripheral joint disease, prevented joint damage, and produced clear or almost clear skin in a pair of pivotal, placebo-controlled Phase 3 trials, Novartis announced.
The experimental drug, which is also called AIN457, is a fully human monoclonal antibody selectively inhibits the interleukin-17A protein that is central to the development of PsA and other inflammatory arthritic diseases.
In the FUTURE 1 and FUTURE 2 studies that enrolled a combined total of more than 1000 patients, secukinumab met its primary and key secondary endpoints, which included improving the signs and symptoms of PsA compared with placebo. According to Novartis, the drug was well tolerated in both studies, and its safety profile was consistent with previously reported results from a large psoriasis clinical trial program that involved nearly 4000 patients.
“Effective new therapies are urgently needed for newly PsA-diagnosed patients and for nearly half of PsA patients who are dissatisfied with or not responding to their current treatments,” said Vasant Narasimhan, Global Head of Development at Novartis Pharmaceuticals, in a press release. "Building on the positive data previously reported in psoriasis, we are excited to present the first Phase 3 results of secukinumab in PsA.”
Based on those results, Novartis plans to file an application with the FDA in 2015 for use of secukinumab in PsA, Narasimhan said. That regulatory filling will follow the drug’s application for the treatment of moderate-to-severe plaque psoriasis, which was filed with the FDA in October 2013 and is anticipated to receive approval in late 2014 or early 2015.
In addition to PsA, secukinumab is also being investigated in clinical trials as a treatment for ankylosing spondylitis and rheumatoid arthritis.