FDA panel unanimously backs Novartis' pasireotide

FDA's Endocrinologic and Metabolic Drugs Advisory committee voted 10-0 that efficacy and safety data for pasireotide from Novartis AG (NYSE:NVS; SIX:NOVN) support approval to treat Cushing's disease. Novartis submitted the application on Feb. 17 and said it expects a decision for the somatostatin analog this year. The PDUFA date is not disclosed. The European Commission approved pasireotide in April as Signifor. Cushing's disease is a form of Cushing's syndrome, a hormone disorder caused by high levels of cortisol in the blood. In Cushing's disease, excess cortisol production is triggered by an adrenocorticotropic hormone (ACTH)-secreting pituitary adenoma. ...