On December 23, 2014, the FDA approved liraglutide, under the name Saxenda, to treat obesity, after having previously approved it under the name Victoza to treat type 2 diabetes mellitus (T2DM).
As Saxenda, the glucagon-like peptide-1 (GLP-1) receptor agonist will be approved for adults with a body mass index (BMI) of 30 or higher, or for adults with a BMI of 27 or higher plus at least 1 other comorbidity, such as T2DM or high cholesterol. The FDA specifically warned against patients taking any other GLP-1 drugs along with Saxenda, including Victoza.1
While the 2 drugs contain the same active ingredient, the approved dose for Saxenda is higher, at 3 mg, than for Victoza, at 1.8 mg.1 The approval for Saxenda (liraglutide [rDNA origin] injection) is based on results from a clinical trial that enrolled patients without diabetes, which showed that patients had an average weight loss of 4.5% from baseline compared with those receiving
placebo for 1 year. In the trial, 62% of patients treated with Saxenda lost at least 5% of their body weight compared with 34% of those treated with placebo.
In another clinical trial, at the 1-year mark, patients with T2DM had an average weight loss of 3.7% from baseline compared with those receiving placebo. In this trial, 49% of patients treated with Saxenda lost at least 5% of their body weight compared with 16% of patients treated with placebo.
In a statement, the FDA said patients who receive Saxenda should be evaluated after 16 weeks to see if the drug is working, and the drug should be stopped if a patient has not lost at least 4% of
baseline body weight. Saxenda has a boxed warning stating that tumors of the thyroid gland have been observed in studies with rodents, but that it is unknown whether the drug causes thyroid tumors in humans. Persons with a family history of medullary thyroid carcinoma or those with multiple endocrine neoplasia syndrome type 2 should not take the drug. The FDA also ordered several post marketing studies for Saxenda. Common side effects were nausea, diarrhea, constipation, vomiting, low blood sugar, and decreased appetite.1
In a statement, manufacturer Novo Nordisk said Saxenda will be launched in the first half of 2015. “Many people suffer from comorbidities. Saxenda has the potential to help some of those people
achieve and maintain a clinically significant weight loss and improve their weight-related comorbidities,” said Mads Krogssgaard Thomsen, executive vice president and chief science officer.2
1. FDA approves weight management drug
Saxenda [press release]. Silver Spring, MD: FDA
Newsroom; December 23, 2014. http://www
2. Novo Nordisk receives FDA approval for
Saxenda® (liraglutide [rDNA origin] injection)
for chronic weight management [press release].
Plainsboro, NJ: PR Newswire; December 24,