BioCentury
ARTICLE | Top Story

FDA committee to discuss CV risks of DPP-4s

April 10, 2015 11:40 PM UTC

FDA's Endocrinologic and Metabolic Drugs Advisory Committee will meet on April 14 to discuss results from two CV outcomes trials of dipeptidyl peptidase-4 ( DPP-4) inhibitors marketed by AstraZeneca plc (LSE:AZN; NYSE:AZN) and Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) to treat Type II diabetes. FDA will ask the committee to vote on recommended regulatory actions, such as additional study requirements, label changes or withdrawal from the market, for both companies' drugs based on overall safety data.

AZ's SAVOR trial of Onglyza saxagliptin and Takeda's EXAMINE trial of Nesina alogliptin were conducted to fulfill FDA's postmarketing requirements. ...