FDA Panel Calls for Cardio Studies for Diabetes Drugs

Donna Young, Washington Editor Released : Wednesday, July 02, 2008 8:40 PM SILVER SPRING, Md. - Companies investigating new drugs and biologics to treat diabetes should be required to routinely conduct additional preapproval testing of their products to rule out cardiovascular risks, a panel of experts told the FDA Wednesday in a 14 to 2 vote. However, the agency's Endocrinologic and Metabolic Drugs Advisory Committee was split on whether drugmakers should be required to conduct a single long-term preapproval trial or something like a two-step study, which would consist of a preapproval screening assessment followed by a postapproval confirmatory study. All drugs currently approved by the FDA to treat diabetes are indicated to improve glycemic control and are approved on the basis of hemoglobin A1c. But concerns have been... [read full story]