In a press statement the company has 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."
Dr Georg van Husen, Corporate Senior Vice President, Head of the Therapeutic Area CardioMetabolism, Boehringer Ingelheim said, “This approval is another example of our commitment to the discovery and development of treatment options for adults with type 2 diabetes. We believe that Jardiance is an important treatment option for this patient population.”
Jardiance is not for people with type 1 diabetes or those with diabetic ketoacidosis (increased ketones in the blood or urine), the release 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,” said Sharad Tyagi, Managing Director, Boehringer Ingelheim India.
Tyagi said, “This breakthrough approval from the U.S. FDA shows our commitment towards providing novel and innovative treatment options for diabetes management.”
In the trial, Jardiance demonstrated a significant 38 percent reduction in the risk of cardiovascular death (HR 0.62, 95% CI: 0.49-0.77); absolute risk reduction was 2.2 percent for patients taking Jardiance versus placebo. There was no significant change in the risk of ‘non-fatal’ heart attack or ‘non-fatal’ stroke. The cardiovascular benefits of Jardiance were consistent among the patient subgroups.
In 2014, Jardiance was approved by the U.S.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 as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus.
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