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FDA reviewers back Novartis' psoriasis mAb

October 17, 2014 2:45 AM UTC

FDA reviewers said "available data support a favorable benefit-risk assessment" for Cosentyx secukinumab from Novartis AG (NYSE:NVS; SIX:NOVN) to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. The reviewers said there have been no identified major safety issues associated with Cosentyx.

The comments came in IgG1 mAb targeting IL-17A. The specific PDUFA date is not disclosed; Novartis submitted the application in October 2013. ...