FDA Grants Approval for Novo Nordisk’s Weight Drug
The FDA has approved Novo Nordisk’s Saxenda (liraglutide) for chronic weight management among obese patients aged 12 and older as an adjunct to a reduced-calorie diet and greater physical activity.
The agency is requiring a boxed warning for the product about the risk of thyroid C-cell tumors. The most common adverse reactions reported in the pediatric clinical trial included gastrointestinal side effects, dizziness and fever. Low blood sugar occurred in 15 percent of patients receiving Saxenda compared to 4 percent of patients receiving placebo.
Treatment should be discontinued if pancreatitis is suspected. Patients should also be monitored for acute gallbladder disease, heart rate increase, kidney impairment and hypersensitivity allergic reactions, the FDA said.