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Novartis receives two new FDA approvals

Novartis announced that the US Food and Drug Administration (FDA) has approved Cosentyx® (secukinumab) for the treatment of two new indications - adults with active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA). AS and PsA are both life-long, painful and debilitating inflammatory diseases that affect the joints and/or spine. If not treated effectively, both conditions can lead to irreversible joint and/or spinal bone damage caused by years of inflammation.

Cosentyx is the first in a new class of medicines called interleukin-17A (IL-17A) inhibitors to treat both AS and PsA. 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.

In the US, it is estimated that up to 0.5% of the population have AS, and up to 1% live with PsA. If not treated effectively, these conditions can lead to irreversible damage to the spine and joints, causing life-long pain and disability that can have a negative impact on even simple tasks in life. There is an urgent unmet need for new medicines for these conditions. Currently many patients are dissatisfied with their treatments, and up to 40% do not respond sufficiently to anti-tumor necrosis factor-alpha (anti-TNFs) therapy.