If the FDA says yes, a new weight loss medication may soon hit the shelves. Novo Nordisk has filed for FDA approval for a new high-dose formulation of its popular diabetes drug liraglutide to be prescribed specifically for weight loss. Liraglutide, currently sold in 1.2 and 1. mg doses under the brand name Victoza and already a blockbuster for Novo Nordisk, has shown major weight loss benefits in recent studies. (In conjunction with diet and exercise, of course.)
In clinical trials, liraglutide helped those taking it lose 5 to 10 percent of their body mass, according to research published in the International Journal of Obesity. And while this study looked at people with diabetes, a previous study published in the Lancet tested the drug in non-diabetics and found similarly impressive weight loss.
In late December, Novo Nordisk filed two submissions for liraglutide, a new drug application (NDA) with the FDA, and a Marketing Authorization Application (MAA) with the European Medicines Agency, according to Drug Discovery & Development. But some folks may not have to wait even that long. In February, Novo Nordisk made the unusual move of targeting Mexico for an initial approval of high-dose liraglutide.
Liraglutide works by mimicking a hormone known as GLP-1, which slows digestion and stimulates the body’s natural production of insulin. Victoza has been very successful for Novo Nordisk, with sales jumping 58 percent in 2012, and climbing an additional 14 percent in the third quarter of 2013.
Experts are projecting that liraglutide would have blockbuster potential as a weight loss application because the market for weight loss is so large.
The study in non-diabetics, conducted by Arne Astrup of the University of Copenhagen, tested four different doses of liraglutide: (1.2 mg, 1.8 mg, 2.4 mg, and 3.0 mg) against placebo and another drug, Orlistat and found that people taking the highest dosage of liraglutide lost an average of almost 16 pounds. People taking the lower doses also lost weight, between 10 pounds with 1.2 mg and 13 pounds at 2.4 mg.
Just as exciting, liraglutide was found to lower blood sugar in participants who had pre-diabetes, lower blood sugar, and even help reduce sleep apnea. The most common side effects from liraglutide were mild; some participants experienced nausea,vomiting and diarrhea when they first started taking the drug but in most cases the problems subsided over time.
However, there are also more serious safety concerns; currently the FDA is investigating the entire class of GLP-1 drugs to see if they raise the risk of pancreatitis. Victoza also carries a warning that animal studies found it caused thyroid tumors, both benign and cancerous, in mice, and that it’s “not known” if it could carry the same risk for humans.
And then there’s the fact that liraglutide is administered as an injection, which will likely prove a barrier for many people, especially given the availability of oral weight loss drugs like Qsymia and Belviq.
Another GLP-1 analog drug with weight loss potential, Sanofi’s Lyxumi, launched in Europe in late 2013, but the company recently withdrew it’s application for FDA approval in the U.S. pending an investigation into the drug’s cardiovascular safety. Eli Lilly’s GLP-1 analog, dulaglutide, is also in the pipeline, projected to launch in 2015, and pharmacists project weight loss benefits will determine which drug is most successful.