The Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee discussed on the approval and recommendations for two diabetic drugs.
The committee voted against any harsh measures, recommending only that information from two neutral clinical trials with the drugs be added to the drugs' labels and rejected withdrawal or new restrictions.
AdvertisementThe trials on two DPP-4 inhibitors, saxagliptin and alogliptin, concluded that the results show no evidence of either cardiovascular benefit or harm. DPP-4 inhibitors reduce glucagon and blood glucose levels and increases incretin levels, which increase insulin secretion and decreases gastric emptying.
SAVOR-TIMI 53 studied saxagliptin (Onglyza, AstraZeneca) and EXAMINE studied alogliptin (Nesina, Takeda Pharmaceuticals). FDA reviewers raised concerns about a possible increase in death with the drugs. Panel members were unable to find any consistency in the data and expressed concerns over a consistent signal for heart failure complications.
Panel members called on the FDA to get companies to study the heart failure question more closely. Without any evidence of cardiovascular benefit, the panelist said, "the diabetes community needs to demonstrate that lowering HbA1c is beneficial."