FDA approvals
2019 GLP-1 FDA approvals & regulatory actions
2 regulatory events affecting GLP-1 medications in 2019.
- Original approval
Rybelsus
First oral GLP-1 receptor agonist approved — once-daily tablet semaglutide for type 2 diabetes. Required strict 30-min fasting protocol for absorption.
Read on fda.gov → - New indication
Victoza
FDA approved Victoza for treatment of type 2 diabetes in pediatric patients aged 10 years and older — first non-insulin T2D treatment approved for pediatric use since 2000.
Read on fda.gov →