Novo Nordisk's diabetes drug lands FDA approval, with caveats

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The FDA has approved liraglutide (Victoza, Novo Nordisk) for its use as treatment in patients with type 2 diabetes.

Liraglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, works to control blood sugar levels by producing insulin to prevent glucose in the blood.

The FDA said that liraglutide is intended to be used in conjunction with diet and exercise and is not recommended as a first-line therapy for patients who have “not achieved adequate diabetes control on diet and exercise alone.”

According to the agency, the drug should be used with caution in patients who have a history of pancreatitis. Also, patients experiencing severe abdominal pain, with or without nausea, should cease taking liraglutide. Five clinical trials with more than 3,900 people found that pancreatitis occurred more in patients who took liraglutide, than patients administered other diabetes medicine.

The FDA has approved the drug with caveats. Post-marketing requirements under the FDA’s Amendments Act call for Novo to conduct studies that will further examine the safety and efficacy of liraglutide. In addition, the drug was approved with a Risk Evaluation and Mitigation Strategy by the agency that consists of a medication guide and communication plan to help patients and physicians understand the risks associated with the drug.