Two new US approvals for Novartis’ Cosentyx
pharmafile | January 18, 2016 | News story | Research and Development, Sales and Marketing | Cosentyx, Novartis
Novartis has won FDA approval for Cosentyx (secukinumab) for the treatment of two new indications – adults with active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA), the company has announced.
The two new indications follow the earlier FDA approval for Cosentyx in January 2015 to treat adult patients with moderate-to-severe plaque psoriasis, and European approval for AS and PsA in November 2015.
The approvals are based the results of four placebo-controlled Phase III studies, which included over 1,500 adult patients with AS or PsA that were biologic treatment naïve or had an inadequate response to existing anti-TNF treatments.
Cosentyx is the first in a new class of medicines called interleukin-17A inhibitors to treat both AS and PsA- both life-long, painful and debilitating inflammatory diseases that affect the joints and/or spine, which can lead to irreversible joint and/or spinal bone damage if left untreated.
“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,” says David Epstein, division head, Novartis Pharmaceuticals. “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 the US, it is estimated that up to 0.5% of the population have AS, and up to 1% live with PsA. Novartis says there is an urgent unmet need for new medicines for both conditions, as many patients are dissatisfied with their treatments, and up to 40% do not respond sufficiently to existing therapies.
Joel Levy
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