Boehringer Ingelheim, Lilly receive FDA OK for Jardiance
The Food and Drug Administration has cleared Boehringer Ingelhein and Lilly’s Jardiance (empagliflozin) 10 mg and 25 mg tablets to lower blood sugar in children 10 years and older with Type 2 diabetes. The drug should be used in tandem with diet and exercise.
"As the burden of Type 2 diabetes increases among young people, so does the need for additional treatment options with proven clinical benefits," said Lennart Jungersten, senior vice president of medicine and regulatory affairs at Boehringer Ingelheim. "This FDA approval, which is based on the efficacy results and safety data from the DINAMO trial, marks an important milestone in helping address a clear unmet need for oral treatment options, in addition to metformin, to lower A1c in this rapidly rising population."
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Type 2 diabetes represents a significant and growing health concern among young people in the United States. Over the past two decades, the prevalence of Type 2 diabetes in people aged 10-19 has nearly doubled. New treatment options are critical to help address the over 5,700 new cases of Type 2 diabetes in this population each year in the United States, the companies said.
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"With this latest FDA decision, Jardiance is now approved to lower A1c along with diet and exercise in children 10 years and older with Type 2 diabetes," said Leonard Glass, senior vice president of diabetes and obesity global medical affairs at Lilly. "This decision brings us one step closer in our efforts to improve outcomes for this population and supports our larger commitment to advance treatment options for people living with a range of cardiometabolic conditions."
Jardiance is used to: reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure, when the heart cannot pump enough blood to the rest of your body; reduce the risk of cardiovascular death in adults with Type 2 diabetes who also have known cardiovascular disease; lower blood sugar along with diet and exercise in adults and children who are 10 years of age and older with Type 2 diabetes.