BASEL (dpa-AFX) - Novartis AG (NVS) Friday said that the Committee for Medicinal Products for Human Use has given a positive opinion on its psoriasis drug, Cosentyx or secukinumab, for treating adults with moderate-to-severe psoriasis in Europe.
The CHMP recommendation will be reviewed by the European Commission, whose approval is granted typically in about two months from receiving an opinion from CHMP.
The company said Phase 3 studies of secukinumab showed that, after 16 weeks of treatment, a 300mg dose of the drug resulted in clear skin, a Psoriasis Area Severity Index of 100, or almost clear skin, a PASI of 90, in 70 percent or more patients.
The drug has been recommended by Dermatologic and Ophthalmic Drugs Advisory Committee, for approval by the US Food and Drug Administration.
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