FDA Approves Second Generic Daily GLP-1 Drug for T2D
The US Food and Drug Administration has approved a generic once-daily injectable version of the glucagon-like peptide-1 receptor agonist (GLP-1 RA) liraglutide (Victoza, Novo Nordisk) to lower blood sugar in people aged 10 years or older with type 2 diabetes (T2D), as an adjunct to diet and exercise.
The move follows the FDA’s approval last month of a generic version of exenatide (Byetta, Amylin Pharmaceuticals). The FDA has prioritized these approvals to improve access to GLP-1 medications in the midst of shortages, according to an FDA statement.
“The FDA supports development of complex generic drugs, such as GLP-1s, by funding research and informing industry through guidance as part of our ongoing efforts to increase access to needed medications,” said Iilun Murphy, MD, director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research. “Generic drugs provide additional treatment options which are generally more affordable for patients. Today’s approval underscores the FDA’s continued commitment to advancing patient access to safe, effective and high-quality generic drug products.”
The most common side effects reported in the clinical trials for liraglutide injection include nausea, diarrhea, vomiting, decreased appetite, dyspepsia, and constipation.
Liraglutide was first approved by the FDA in January 2010 for the treatment of T2D. Since then, numerous other GLP-1 RA‒based medications have been approved for treating T2D, obesity, and other related conditions, in once-weekly and oral formulations.
The new generic approval is part of the FDA’s Drug Competition Action Plan, launched in 2017 with the aim of overcoming challenges related to developing generics and promoting generic competition to increase patient access, particularly with complex drug products such as liraglutide.
The FDA granted the approval of generic liraglutide injection to Hikma Pharmaceuticals USA Inc.
Miriam E. Tucker is a freelance journalist based in the Washington, DC, area. She is a regular contributor to Medscape, with other work appearing in the Washington Post, NPR’s Shots blog, and Diatribe. She is on X (formerly Twitter) @MiriamETucker.
