
FDA approves two Type 2 Diabetes drugs for use in children
FDA approves Jardiance and Synjardy for pediatric use.
The FDA has
Metformin, the only other oral therapy available for the treatment of children with type 2 diabetes, was first approved for pediatric use in 2000.
Michelle Carey, M.D.
“Compared with adults, children with type 2 diabetes have limited treatment options, even though the disease and symptom onset generally progress more rapidly in children,” Michelle Carey, M.D., M.P.H., associate director for therapeutic review for the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, said in a press release.
The FDA approval “marks an important milestone in helping address a clear unmet need for oral treatment options, in addition to metformin, to lower A1c in this rapidly rising population,” Lennart Jungersten, M.D., Ph.D., senior vice president of Medicine & Regulatory Affairs at Boehringer Ingelheim,
The blockbuster diabetes medication Jardiance was also granted an
The FDA
As of 2017, there were about 28,000 cases of type 2 diabetes in children in the United States, according to the FDA. “By 2060, if current trends continue, that number is predicted to be about 220,000, with the majority of cases occurring in minority racial and ethnic groups such as Non-Hispanic Blacks and Hispanics,” the agency said.
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