Eli Lilly says FDA panel backs approval of Jardiance for cardiovascular indication
pharmafile | June 30, 2016 | News story | Research and Development, Sales and Marketing |Â Â Eli Lilly, cardiovascular, diabetes, jardianceÂ
US drugmaker Eli Lilly (NYSE: LLY) said a US regulatory panel has backed its Jardiance (empagliflozin) for reducing cardiovascular death in adults with type 2 diabetes and heart condition.
The company said the US Food and Drug Administration advisory committee voted 12-11 in favour odf the drug. Jardiance, which is marketed by Boehringer Ingelheim and Eli Lilly is the only oral type 2 diabetes medicine shown in a clinical trial to reduce the risk of cardiovascular death.
The recommendation was made by the Endocrinologic and Metabolic Drugs Advisory Committee based on data from the study, which showed that Jardiance significantly reduced the risk of the combined endpoint of cardiovascular death, non-fatal heart attack or non-fatal stroke by 14% in combination with standard care.
The primary finding was driven by a 38% reduction in cardiovascular death, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke.
Jardiance is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
About 29 million Americans and an estimated 415 million people worldwide have diabetes, and nearly 28% of Americans with diabetes—totalling 8 million people—are undiagnosed. In the US, about 12% of those aged 20 and older have diabetes. Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.
Due to the complications associated with diabetes, such as high blood sugar, high blood pressure and obesity, cardiovascular disease is a major complication and the leading cause of death associated with diabetes. In 2015, diabetes caused 5 million deaths worldwide, with cardiovascular disease as the leading cause.
Anjali Shukla
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