Mumbai : Pharma firm Boehringer Ingelheim said it has got approval from the US health regulator for a new indication for Jardiance (empagliflozin) tablets, used to reduce the risk of cardiovascular death in adults with type 2 diabetes.
In a statement here, the company said, “We have received the US Food and Drug Administration (FDA) approval for a new indication for Jardiance (empagliflozin) tablets, used to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.”
Jardiance, marketed by Boehringer, is the first type 2 diabetes treatment approved with this additional indication and the only oral type 2 medicine shown in a clinical trial to provide a life-saving cardiovascular benefit.
Jardiance is not for people with type 1 diabetes or those with diabetic ketoacidosis (increased ketones in the blood or urine), the statement said.
“As the only diabetes treatment approved by the FDA to reduce the risk of cardiovascular death, Jardiance represents a tremendous step forward in our efforts to reduce the impact of heart disease among adults with type 2 diabetes and cardiovascular disease,” Boehringer Head of Therapeutic Area CardioMetabolism Georg van Husen Said.
“This approval is another example of our commitment to the discovery and development of treatment options for adults with type 2 diabetes,” he said.
“Globally, the prevalence of type 2 diabetes is high and is reaching alarming proportions in many countries, especially India. With the FDA approval, Jardiance is a proven option for reducing cardiovascular mortality in adult patients of type-2 diabetes, having cardiovascular disease.
“This breakthrough approval from the US FDA shows our commitment towards providing novel and innovative treatment options for diabetes management,” Boehringer India Managing Director Sharad Tyagi said.
In 2014, Jardiance was approved by the US FDA as an adjunct to diet and exercise to improve glycemic control, or blood glucose levels, in adults with type 2 diabetes. In India, Jardiance is currently approved for use an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.