New Weight Loss Formula: Popular Diabetes Drug Melts Pounds, Studies Show
Melanie Haiken | April 30, 2014.
If the FDA says yes, a major new weight loss drug may hit the market this year. A high-dose formulation of liraglutide, the popular diabetes drug from Novo Nordisk melts up to 10 percent of body mass, studies show.
Liraglutide, available in 1.2 mg and 1.8 mg doses as Victoza, is already a huge success for Novo Nordisk. The company has now filed with the FDA seeking approval for a 3.0 mg dose after studies found major weight loss benefits (in conjunction with diet and exercise.)
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. And others may not wait at all; while the studies warn against using liraglutide “off-label” for weight loss, it seems certain that patients will seek to use Victoza for that purpose.
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 reduce pre-diabetes, lower blood pressure, 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 a daily injection, which will likely prove a barrier for many people, especially given the availability of oral weight loss drugs like Qsymia and Belviq.
A Class of Potential Weight Loss Cures
Liraglutide belongs to a class of drugs known as incretin mimetics, all of which may turn out to be potential weight loss cures.
AstraZeneca's evenatide (Byetta, Bydureon) the other GLP-1 analog on the market, has also been found to aid weight loss, and the obesity community is taking notice. Weight loss bulletin boards are a-buzz with questions, and health experts like Mayo Clinic are beginning to weigh in on the issue.
Meanwhile, more GLP-1 analogs come down the pipeline. Just a few weeks ago the FDA approved albiglutide (Tanzeum), GlaxoSmithKline's GLP-1 contender, which only has to be injected once-a-week.
And the FDA is currently reviewing Eli Lilly‘s GLP-1 analog, dulaglutide, which appears to be as promising for weight loss as liraglutide, and also has once-a-week dosage. Eli Lilly hopes to have dulaglutide in pharmacies by the end of 2014. Pharmacists project weight loss benefits may be just as important as diabetes control in determining which GLP-1 drug is most successful.
Sanofi's GLP-1 analog 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.