Cosentyx was previously approved for the treatment of moderate-to-severe plaque psoriasis.
The FDA on Friday granted approval to a new drug for the treatment of ankylosing spondylitis (AS) and active psoriatic arthritis (PsA).
AS is an inflammatory disease that causes some of the vertebrae in the spine to fuse together. It affects up to 0.5% of people in the United States. PsA occurs when swelling, pain, or stiffness occurs in and around the joints, which affects up to 1% of the population.
Both of these conditions are painful and debilitating, making it difficult to complete simple everyday tasks.
The drug secukinumab (Cosentyx), manufactured by Novartis Pharmaceuticals, is first in a new class of medicines to treat AS and PsA known as interleukin-17A (IL-17A) inhibitors. The FDA previously approved Cosentyx for the treatment of moderate-to-severe plaque psoriasis.
The FDA approvals of the new indications follow 4 placebo-controlled phase 3 studies. Researchers took more than 1500 AS or PsA patients, who were biologic treatment naïve, and who didn’t have an effective response or were intolerant to anti-tumor necrosis factor-a therapy.
The results of the trial showed Cosentyx was able to meet the primary endpoints of statistically significant improvements compared with 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 at Week 16, along with a 20% decrease in the American College of Rheumatology response criteria at Week 24.
In clinical trials, researchers found there were more than 9600 patients treated with secukinumab and 15,000 who were treated for psoriasis.
“These new approvals are a potential turning point for people living with ankylosing spondylitis and psoriatic arthritis in the US, as Cosentyx provides a novel and targeted way of inhibiting the inflammatory process of these two conditions,” said Division Head of Novartis David Epstein 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.”