Empagliflozin, which will be marketed under the name Jardiance, has been approved for use for the American public with type 2 diabetes by the US Food and Drug Administration (FDA).
Approval of the drug was confirmed following pre-marketing studies involving 4,480 people that took the drug. However, whilst the drug has received approval, the FDA has asked for additional post-marketing trials to be run to confirm safety. The post-marketing trials will include completion of a trial to assess heart risk and a number of trials to test for safety in children.
The drug is in a group of medications known as SGLT-2 inhibitors, which lower blood glucose levels by allowing the kidneys to remove more glucose from the blood and excrete it in the urine. Two medications from this group, Forxiga (dapgliflozin) and Invokana (canagliflozin) have been approved by the US FDA and the UK’s National Institute for Health and Care Excellence (NICE).
Jardiance has a significant effect on lowering blood glucose levels and HbA1c and showed modest improvements in lowering body weight and blood pressure. Dangerous hypoglycemia should not occur in people that take the drug with metformin, or on its own, but was found to be more commonly reported in those …read more
Source: News from Diabetes.co.uk