FDA approves two new indications for Novartis’ Cosentyx psoriasis drug

The drug has now been approved to treat adults with active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA) inflammatory diseases, which affect the joints and/or spine.

The approval is based on efficacy and safety outcomes demonstrated in four phase III trials, including more than 1,500 patients with either AS or PsA.

In studies, Cosentyx met the primary endpoints showing statistically significant enhancements, when compared to placebo in the indications and symptoms of AS and PsA.

Novartis Pharmaceuticals division head David Epstein said: "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.

"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."

The European Commission approved the two new indications of Cosentyx in November last year. It is also approved to treat AS and PsA in Ecuador and Bangladesh, and for the treatment of PsA in Japan.

Cosentyx is a fully human monoclonal antibody that selectively neutralizes circulating interleukin-17A. It has already been approved in the US and EU to treat adults with moderate-to-severe plaque psoriasis.

Image: Novartis headquarters in Basel. Photo: courteys of –Andrew- from Flickr.