Boehringer, Lilly get FDA review for expanded use of Jardiance in adolescents
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- The U.S. Food and Drug Administration (FDA) accepted to review Boehringer Ingelheim and Eli Lilly's (NYSE:LLY) application seeking expanded approval of Jardiance to lower blood sugar, along with diet and exercise, in children 10 years and older with type 2 diabetes.
- Lilly said that if the supplemental new drug application (sNDA) is approved, Jardiance (empagliflozin) would be the first SGLT2 inhibitor indicated for this population.
- The sNDA was backed by data from a phase 3 trial called DINAMO.
- Jardiance was initially approved in 2014, as once-daily tablet, along with diet and exercise to lower blood sugar in adults with type 2 diabetes; and to reduce the risk of cardiovascular death in adults with type 2 diabetes and known cardiovascular disease.
- The drug is also approved to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure.