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FDA posts pasireotide briefing documents

November 6, 2012 2:29 AM UTC

FDA reviewers said pasireotide from Novartis AG (NYSE:NVS; SIX:NOVN) is effective for treating Cushing's disease, but cautioned that the "efficacy results need to be considered in the context of the overall safety profile" of the somatostatin analog. In particular, the reviewers cited the development or worsening of hyperglycemia or diabetes and elevations in liver enzymes in patients receiving pasireotide. Cushing's disease is a form of Cushing's syndrome, a hormone disorder caused by high levels of cortisol in the blood. ...