The FDA has approved Novartis' secukinumab for the treatment of 2 new indications: adults with active ankylosing spondylitis and active psoriatic arthritis.
The FDA has approved Novartis’ secukinumab (Cosentyx) for the treatment of 2 new indications: adults with active ankylosing spondylitis and active psoriatic arthritis.
Ankylosing spondylitis and psoriatic arthritis are chronic inflammatory diseases that impact the joints and spine and can lead to irreversible damage if not treated properly.
"These new approvals are a potential turning point for people living with ankylosing spondylitis and psoriatic arthritis in the United States, as Cosentyx provides a novel and targeted way of inhibiting the inflammatory process of these 2 conditions," said David Epstein, division head of Novartis Pharmaceuticals, in a press release. "The results from our studies have shown that the majority of patients treated with Cosentyx have a significant reduction in their signs and symptoms of ankylosing spondylitis and psoriatic arthritis and show major improvements in their ability to undertake everyday activities."
In January 2015, the FDA approved Cosentyx as a treatment of moderate-to-severe plaque psoriasis in adult patients.
The approvals for the 2 new indications are based on 4 phase 3 studies that looked at the safety and efficacy of the drug.
More than 1500 patients were examined as a part of these studies, and Cosentyx met the primary endpoints of the trials.
Compared with patients who took placebo, the patients treated with Cosentyx saw at least a 20% improvement in the assessment of Spondyloarthritis International Society criteria at week 16 and a 20% reduction in the American College of Rheumatology criteria at week 24.
During clinical trials for several indications, more than 9600 patients have taken Cosentyx.
Cosentyx is a monoclonal antibody that selectively neutralizes IL-17A in the body, which plays a critical role in the immune system’s response to ankylosing spondylitis and active psoriatic arthritis.