FDA actions

FDA actions

The FDA has approved pasireotide diaspartate injection for the treatment of Cushing's disease in patients who are not candidates for surgery or for whom surgery has not worked. The drug is considered an orphan drug. The safety and efficacy were evaluated in a trial of 162 patients with Cushing's disease who were randomized to one of two doses of the drug. About 20% of participants had normal urine cortisol levels within 6 months. Side effects included increased blood sugar levels and liver injury. The drug is administered subcutaneously twice a day. It is marketed by Novartis as Signifor. In February 2012, the FDA approved mifepristone (Korlym) for the treatment of Cushing's syndrome.