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FDA indication reflects REWIND findings

FDA has approved dulaglutide for reducing the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes who have multiple cardiovascular risk factors – with or without established cardiovascular disease – based on the results of PHRI’s REWIND study.

It is the first type 2 diabetes drug approved for primary and secondary prevention populations, according to an Eli Lilly press release, as reported by Helio Endocrine.

“This new indication by the FDA, and the supporting evidence, is important for the millions of people in the U.S. living with diabetes, which is itself a cardiovascular risk factor,” notes Hertzel Gerstein, deputy director of PHRI and the REWIND study chair. “More than 415 million people have type 2 diabetes globally, but only about one-third of them have established cardiovascular disease.”