AstraZeneca PLC (AZN) and Bristol-Myers Squibb Co. (BMY) said Thursday that the U.S. Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee voted 13-1 that the benefits of dapagliflozin use outweigh identified risks and support marketing of dapagliflozin as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
The Advisory Committee also voted 10-4 that the data provided sufficient evidence that dapagliflozin, relative to comparators, has an acceptable cardiovascular risk profile.
The FDA is not bound by the Advisory Committee's recommendation but takes its advice into consideration when reviewing the application for an investigational agent. The Prescription Drug User Fee Act goal date for dapagliflozin is January 11, 2014.
Dapagliflozin is currently approved under the trade name Forxiga for the treatment of adults with type 2 diabetes, along with diet and exercise, in 38 countries, including the European Union and Australia.
For comments and feedback contact: editorial@rttnews.com
June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.