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January 17, 2016

US FDA approves Cosentyx for ankylosing spondylitis and psoriatic arthritis treatment

Swiss drug maker Novartis has secured approvals from the US Food and Drug Administration (FDA) for injectable medication Cosentyx for two new indications, which can now be used to treat patients having ankylosing spondylitis (AS) and psoriatic arthritis (PsA).

Swiss drug maker Novartis has secured approvals from the US Food and Drug Administration (FDA) for injectable medication Cosentyx for two new indications, which can now be used to treat patients having ankylosing spondylitis (AS) and psoriatic arthritis (PsA).

Approval for the medication has been granted after thorough studies on its efficacy and safety outcomes for AS and PsA patients.

Cosentyx had undergone four Phase III studies, which were carried out on more than 1,500 patients having either AS or PsA, which are both life-long, painful and debilitating inflammatory diseases affecting the joints and / or spine.

It is the first in a new class of medicines called interleukin-17A (IL-17A) inhibitors, Novartis said.

"These new approvals are a potential turning point for people living with ankylosing spondylitis and psoriatic arthritis in the US."

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."

In January last year, the medicine was approved by FDA for two new indications for adult patients with moderate-to-severe plaque psoriasis.

Cosentyx had also secured European approval for AS and PsA in November 2015.

Up to 0.5% of the US population is estimated to have been affected by AS, while up to 1% live with PsA.

Without proper medications, the conditions can worsen, leading to irreversible damage to the spine and joints of the patients, causing enduring pain and disability for tasks.

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