The FDA has approved empagliflozin (Jardiance) to improve glycemic control, along with diet and exercise, in patients with type 2 diabetes.
Approximately 26 million patients have been diagnosed with type 2 diabetes, and more than 90% of diabetes cases diagnosed in the United States are type 2 diabetes.
“Empagliflozin is a sodium glucose co-transport 2 (SGLT2) inhibitor. It works by blocking the reabortion of glucose by the kidney, increasing glucose excretion, and lowering blood glucose levels in diabetes who have elevated blood glucose levels,” wrote the agency in a press release.
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To evaluate the safety and efficacy trials, 4,480 patients diagnosed with type 2 diabetes were assigned to receive empagliflozin or placebo. The pivotal trials showed that empagliflozin improved HbA1c levels compared with placebo.
The FDA is requiring the following postmarketing studies:
- Completion of an ongoing cardiovascular outcomes trial
- A pediatric pharmacokinetic/pharmacodynamic study
- A pediatric safety and efficacy study, which will also assess the drug’s affect on bone health and development
- A nonclinical (animal) juvenile toxicity study with a particular focus on renal development, bone development, and growth
“Jardiance should not be used: to treat people with type 1 diabetes; in those who have increased ketones in their blood or urine (diabetic ketoacidosis); and in those with severe renal impairment, end stage renal disease, or in patients on dialysis,” the FDA said.
