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Novartis Gets FDA Approval For Cosentyx Label Update - Quick Facts

Swiss drug major Novartis AG (NVS) said that the U.S. Food and Drug Administration or FDA has approved a label update for Cosentyx or secukinumab, the first interleukin-17A or IL-17A inhibitor approved to treat moderate-to-severe plaque psoriasis.

The updated label includes Cosentyx data in moderate-to-severe scalp psoriasis - one of the difficult-to-treat forms of the disease, which affects approximately half of all psoriasis patients.

The company said that the label update is effective in the U.S. immediately, and is based on the proven efficacy and consistent safety profile of Cosentyx from a dedicated Phase III scalp psoriasis trial.

The updated label for Cosentyx in scalp psoriasis addresses an important unmet need. Scalp psoriasis can be challenging to treat with topical agents or phototherapy due to the presence of hair and other factors. Approximately half of all 125 million patients with psoriasis suffer from scalp psoriasis.

The label update is based on 12-week primary endpoint results from the SCALP study of moderate-to-severe scalp psoriasis where Cosentyx demonstrated superior efficacy compared to placebo.

Psoriasis is a distressing and painful autoimmune disease that affects more than 125 million people worldwide. It is a debilitating condition associated with a significant emotional and physical daily burden.

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