Novo Nordisk's liraglutide (Saxenda) is now available by prescription in the United States.
Novo Nordisk’s obesity drug, liraglutide (Saxenda), is now available by prescription in the United States.
Approved by the FDA in December 2014, the once-daily glucagon-like peptide-1 (GLP-1) receptor agonist is indicated for chronic weight management alongside a reduced-calorie diet and physical activity in obese adults with a body mass index (BMI) ≥30 kg/m2 or overweight adults with a BMI ≥27 kg/m2 and at least 1 weight-related comorbid condition, such as hypertension, type 2 diabetes, or dyslipidemia.
Saxenda’s FDA approval was partly based on results from the phase 3 Satiety and Clinical Adiposity-Liraglutide Evidence in Nondiabetic and Diabetic people (SCALE) clinical trial program, which involved more than 5000 obese or overweight participants. The data showed Saxenda treatment combined with a reduced-calorie diet and increased physical activity resulted in greater weight loss than the lifestyle modifications alone.
“We are pleased to make this new treatment option available, which we believe has the potential to help people with obesity lose weight and reduce weight-related comorbidities,” said Novo Nordisk executive vice president Jakob Riis in a press release. “The launch of Saxenda is an important milestone in Novo Nordisk's long-term commitment to obesity treatment.”
Patients using Saxenda should be evaluated after 16 weeks to determine the treatment’s effectiveness. If a patient has not lost at least 4% of his or her baseline body weight by that point, Saxenda should be discontinued, as it is unlikely the patient will achieve and sustain clinically meaningful weight loss with continued treatment.
Saxenda’s boxed warning states that while thyroid C-cell tumors have been observed in rodent studies with Saxenda, it is unknown whether Saxenda causes thyroid C-cell tumors, including a type of thyroid cancer called medullary thyroid carcinoma (MTC), in humans. Saxenda should not be used in patients with a personal or family history of MTC or in patients with multiple endocrine neoplasia syndrome type 2.