FDA Approves New Class of Oral Medicines for Children with Type 2 Diabetes

On Tuesday, the FDA approved Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as additions to diet and exercise to improve blood sugar control in children ten years and older with type 2 diabetes. 

These approvals provide a new class of medicines taken by mouth to treat pediatric type 2 diabetes. 

The FDA granted approvals of Jardiance and Synjardy to Boehringer Ingelheim.

Metformin, the only other oral therapy available for children with type 2 diabetes, was first approved for pediatric use in 2000.

Jardiance and Synjardy were first approved by the FDA in 2014 and 2015, respectively, for treating type 2 diabetes in adults.

The approvals were based on a study that showed patients between 10 years and 17 years recorded lower average blood sugar compared with placebo when treated with empagliflozin.

Back in January 2011, Boehringer Ingelheim and Eli Lilly And Co LLY announced an alliance in diabetes that centers on compounds representing several of the largest diabetes treatment classes. 

Empagliflozin, the active ingredient in Jardiance and Synjardy, works by increasing the excretion of glucose in the urine. Synjardy also contains metformin.

Price Action: LLY shares are up 0.44% at $453.94 during the premarket session on the last check Wednesday.