BRIEF—FDA nod for Jardiance and Synjardy for pediatric type 2 diabetes

The US Food and Drug Administration has approved Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as additions to diet and exercise to improve blood sugar control in children 10 years and older with type 2 diabetes.

The FDA granted these approvals of Jardiance and Synjardy to Germany’s Boehringer Ingelheim, which markets the drugs in partnership with US pharma major Eli Lilly.

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

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

Jardiance was originally approved by the FDA in 2014 as an addition to diet and exercise to improve blood sugar control in adults with type 2 diabetes, while Synjardy was originally approved by the FDA in 2015 for the same indication.