December 17, 2012
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FDA approves Signifor to treat Cushing’s disease
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The FDA announced approval of Novartis’s pasireotide injection for the treatment of Cushing’s disease in adults who do not have the option to undergo pituitary surgery or in whom surgery has not been curative.
On November 7, 2012, the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted unanimously for the approval of Signifor. It is the second drug labeled specifically to treat hypercortisolemia.
As previously reported in Endocrine Today, despite concerns on glucose control, the panel decided that the safety and efficacy data for pasireotide is sufficient to support the marketing of this drug.