FDA Approves Diabetes Medication for Teens
Eli Lilly and Boehringer Ingelheim have recently received approval from the FDA to expand the usage of empagliflozin, also known as Jardiance. This medication helps regulate blood sugar levels and was initially approved for adults with type 2 diabetes in 2014. However, it can now be used in teens aged 10-17 years with this condition when combined with a proper diet and exercise regimen. It may also be prescribed alongside metformin, another oral therapy for children with type 2 diabetes. To differentiate its use among teenagers, Jardiance will be marketed as Synjardy.
This approval is noteworthy because it makes Jardiance the first substance of its kind (referred to as an SGLT2 inhibitor) allowed for use in adolescents facing type 2 diabetes. Companies like Eli Lilly and Boehringer Ingelheim possess strong evidence that emphasizes effectively managing blood sugar levels early on is crucial in those living with type 2 diabetes.
The FDA’s decision was primarily based on data obtained from the Phase III DINAMO trial, during which empagliflozin exhibited significant reduction of A1c levels (a measurement concerning blood sugar control) compared to a placebo in individuals aged between ten and seventeen years old. Participants involved had baseline A1c measurements ranging from 6.5% to 10.5%.
It should be noted that researchers observed consistent safety profiles regarding empgaliflozin when administered to both adults and adolescents alike; however, the FDA acknowledged that children above ten years old experienced a higher risk of low blood sugar regardless of additional diabetes therapies they were receiving.
Unfortunately, there has been an increasing prevalence of type 2 diabetes amongst children nowadays; if this trend persists, young individuals may experience significantly high incidences of developing this condition later on. Presently speaking, treatment options for children diagnosed with type two diabetic conditions are limited.
Jardiance, alongside medications like Glyxambi, Synjardy, and Trijardy, have observed considerable sales within the previous year. Additionally, Jardiance has also been approved for cardiac-related conditions and competes favorably with other SGLT2 inhibitors available in the market.
It is worth noting that Boehringer Ingelheim had tested an alternative medication known as Tradjenta (or linagliptin) on adolescents diagnosed with type 2 diabetes; however, it did not display any statistically significant reduction in blood sugar levels. Presently speaking, both empagliflozin and linagliptin are permitted for combined use among adults living with type 2 diabetes.
Later this year, the FDA is anticipated to make a decision regarding whether or not to approve Jardiance for reducing the risk of kidney disease progression and cardiovascular death amongst adult individuals battling chronic kidney disease.
Source – FDA Approves Diabetes Medication for Teens
