FDA approves Signifor (Novartis) for treatment of Cushing's Disease

The FDA Endocrinologic and Metabolic Drugs Advisory Committee has voted unanimously in support of the use of Signifor (pasireotide) from Novartis, for the treatment of patients with Cushing's Disease who require medical therapeutic intervention. The recommendation was based on data from clinical trials of pasireotide, including PASPORT-CUSHINGS (PASireotide clinical trial PORTfolio - CUSHING'S disease), the largest randomized Phase III study to evaluate a medical therapy in patients with Cushing's Disease. Although not obliged to follow the recommendation, the FDA can seek the advice of its advisory committees as it reviews and decides whether to approve treatments. Signifor was approved by the European Commission for this indication in April 2012.