FDA actions

FDA actions

Responding to concerns about increasing antibiotic resistance, the FDA has issued an order that prohibits the use of cephalosporins in cattle, swine, chickens, and turkeys effective April 15, 2012. This rule is intended to limit the indiscriminate use of cephalosporins and preserve the effectiveness of the drugs in humans.

The FDA has approved a once-weekly, extended-release formulation of exenatide for treatment of type 2 diabetes. The drug is a glucagon-like peptide-1 receptor agonist and is indicated as an adjunct to diet and exercise for improved glycemic control. It is the first once-weekly diabetes drug to be approved. The approval was based on the DURATION-5 trial, which compared once-weekly exenatide with twice-daily exenatide injection. Exenatide extended-release is approved with a Risk Evaluation and Medication Strategy (REMS) because of concerns regarding acute pancreatitis and the potential risk for medullary thyroid cancer, as well as concerns about QT prolongation and cardiovascular risk. Exenatide extended-release will be marketed by Amylin Pharmaceuticals and Alkermes plc as Bydureon.

The FDA has approved vismodegib to treat adult patients with advanced basal cell carcinoma who are not candidates for surgery or radiation, and for patients with metastatic disease. The drug was approved under the agency's priority review program and is the first approved drug for metastatic basal cell carcinoma. The once-a-day oral pill inhibits the Hedgehog pathway, a molecular pathway found in basal cell carcinomas but few other normal tissues. The approval was based on a single, multicenter trial of 96 patients in which 30% of patients with metastatic disease experienced a partial response and 43% patients with locally advanced disease experienced a complete or partial response. Vismodegib is marketed by Genentech as Erivedge.