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FDA approves Novartis' Signifor for Cushing's

December 15, 2012 2:04 AM UTC

FDA approved late Friday an NDA from Novartis AG (NYSE:NVS; SIX:NOVN) for Signifor pasireotide to treat Cushing's disease when surgery is not an option or has failed. As part of the approval, the pharma is required to conduct three postmarketing studies: a clinical trial to assess hyperglycemia management; a long-term observational study; and a safety monitoring study for reports of serious hyperglycemia, acute liver injury and adrenal insufficiency.

In November, an FDA panel voted 10-0 that the efficacy and safety data support approval of the somatostatin analog. Reviewers had noted in briefing documents before the panel that the drug was associated with the development or worsening of hyperglycemia or diabetes and elevations in liver enzymes. The European Commission approved pasireotide in April. ...