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FDA Approves Signifor (Pasireotide Diaspartate) for Cushing’s Disease
The FDA has approved Signifor injection (pasireotide diaspartate, Novartis Pharma Stein AG) for the treatment of patients with Cushing’s disease who cannot be helped with surgery.
In Cushing’s disease, a tumor in the pituitary gland leads to overstimulation of the adrenal gland, which results in excess production of the hormone cortisol. Cortisol regulates many important functions in the body, including the response to stress and injury. Patients with Cushing’s disease may have increased weight, glucose intolerance or diabetes, high blood pressure, easy bruising, and an increased risk for infections.
The safety and effectiveness of Signifor were evaluated in a clinical study of 162 Cushing’s disease patients. The patients were randomly assigned to receive one of two dose levels of Signifor for 6 months. Some patients who safely responded to the drug were allowed to continue treatment. Signifor therapy resulted in decreased cortisol levels, as measured in urine collected over a 24-hour period. This reduction occurred as early as 1 month after the start of treatment. About 20% of the patients were able to reduce their urine cortisol levels into the normal range.
Treatment with Signifor caused increases in blood sugar levels, which could be detected as early as 2 weeks after starting treatment. Continued therapy caused or worsened diabetes in some patients; therefore, patients must be carefully monitored for this side effect and should be treated appropriately with antidiabetic therapies, including insulin.
The FDA is requiring three postmarketing studies for Signifor: a clinical trial to assess the management of hyperglycemia; a long-term prospective observational cohort study of patients with Cushing’s disease treated with Signifor; and focused safety monitoring for reports of serious hyperglycemia, acute liver injury, and adrenal insufficiency.
Signifor is administered subcutaneously twice daily. The most common adverse reactions observed in the clinical trial included hyperglycemia, diarrhea, nausea, abdominal pain, and gallstones.
Source: FDA; December 14, 2012.