(Reuters) – The U.S. Food and Drug Administration (FDA) on Tuesday approved Eli Lilly and partner Boehringer Ingelheim’s drugs Jardiance and Synjardy to treat type 2 diabetes in children.
The drugs were approved as additions to diet and exercise to improve blood sugar control in children aged 10 years and above with type 2 diabetes, the most common form of the disease.
The approvals were based on a study that showed patients aged between 10 years and 17 years recorded lower average blood sugar compared with placebo when treated with empagliflozin – the active ingredient in the two drugs.
Empagliflozin, which works by increasing the excretion of glucose in urine, offers an alternative to pediatric patients for whom diabetes drug metformin has been the only oral treatment.
Jardiance and Synjardy were first approved by the FDA in 2014 and 2015, respectively, for treating type 2 diabetes in adults.
In type 2 diabetes, the body does not make or use insulin normally, leading to high levels of glucose in the blood.
Eli Lilly shares were largely flat in extended trading.
(Reporting by Raghav Mahobe in Bengaluru; Editing by Devika Syamnath)
