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Novartis receives EU approval for Cosentyx psoriasis label update
Novartis has announced that its drug Cosentyx has received European regulatory approval for a new label update that reflects its safety and efficacy in the treatment of psoriasis.
The European Medicines Agency's Committee for Medicinal Products for Human Use has approved a label update that includes 52-week data from the CLEAR study, demonstrating the long-term superiority of Cosentyx compared to an established alternative psoriasis therapy.
The updated label also authorises the use of Cosentyx to treat moderate to severe scalp psoriasis, which is one of the most difficult-to-treat forms of psoriasis. This update is based on the proven efficacy and consistent safety profile of Novartis' drug.
In the CLEAR study, Stelara was shown to deliver long-lasting clear or almost clear skin over one year of treatment in adults with moderate to severe psoriasis, as well as offering better response rates than a comparator drug.
Vas Narasimhan, global head of drug development and chief medical officer of Novartis, said: "Cosentyx is an innovative, groundbreaking treatment for people living with autoinflammatory diseases, and we're proud to continuously expand treatment possibilities for an even greater number of patients."
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