FDA Advisory Committee Supports Novo Nordisk's Liraglutide For Weight Management
By Cyndi Root
The Food and Drug Administration advisory committee voted 14-1 that Novo Nordisk’s liraglutide is safe and effective for obese patients with at least one weight-related issue. According to Reuters, it is likely that the FDA will follow the advisory committee’s recommendation, as it has traditionally done so in the past. Should the FDA officially approve the medication, analysts are speculating that opening up liraglutide as a treatment option in this indication could provide a big financial boost to the company—upwards of $1 billion in revenue, Reuters says.
FDA Liraglutide Review
Leading up to this meeting, which occurred on September 11, 2014, The Food and Drug Administration (FDA) released briefing documents to support its discussion of Novo Nordisk’s New Drug Application (NDA) for liraglutide (intended brand name Saxenda).
Novo Nordisk is seeking an indication for liraglutide as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kilograms per square meter (kg/m2) or greater, or with an initial BMI of 27 kg/m2 or greater in the presence of at least one weight-related comorbidity.
Liraglutide, a selective glucagon-like peptide-1 (GLP-1) receptor agonist, was approved in January 2010 with the brand name Victoza as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Trial Endpoints
The 337-page Briefing Document details the five trials supporting the application, with a summary table available on page 237 and an endpoint summary table on page 239. The document states that the efficacy results are consistent with its 2007 Weight Management Guidance as the primary efficacy endpoints were met.
On page 252 of the report, in the section on efficacy, the FDA states, “Based on our preferred analysis, subjects treated with liraglutide were found to have statistically significant changes in body weight.” Half of the patients being treated with liraglutide for weight management saw losses of at least 5 percent of body weight, while 22 percent lost more than 10 percent.
Liraglutide Safety
The safety of liraglutide in doses of 1.8 mg daily are documented in the diabetes and post-marketing studies. The studies for weight management differed from the previous studies as they used a placebo instead of a comparator drug, the trials were longer, and the dose was higher. The FDA found gallbladder problems and an increase in resting heart rate. However, responding to concerns of pancreatitis or pancreatic or thyroid tumors, the agency stated, “Overall, adjudicated malignancies occurred at a similar rate in liraglutide- and placebo-treated groups.”