Novo Nordisk is seeking FDA approval of a new indication forits diabetes drug, liraglutide. Liraglutide is already approved as a diabetes drug, but Novo Nordisk has been testing liraglutide as a weight loss treatment, and results from a recent study suggest that the drug could reduce up to 10 percent of body mass.
Patients using the drug for weight loss have been extremely successful, losing between 5 and 10 percent of their body mass, according to studies published in the International Journal of Obesity. The International Journal of Obesity published a liraglutide weight loss study looking at patients with diabetes. The Lancet also published a similar study looking at the drug’s effect on weight in patients without diabetes, and found that the taking the drug also inspired significant weight loss.
Liraglutide is currently available for diabetes patients in 1.2 mg and 1.8 mg doses. Novo Nordisk would like the FDA to increase the acceptable dosage to 3.0 mg to enable the drug to be used for weight loss.
In December of 2013, Novo Nordisk filed a new drug application with the FDA for the drug, in addition to a marketing authorization application with the European Medicines Agency. Because the market for weight loss drugs is so strong, some industry analysts believe that liraglutide could be a blockbuster drug for Novo Nordisk. The drug also seems to have other possible indications, as patients taking liraglutide were said to have lowered blood pressure, reduced sleep apnea, and lowered rates of pre-diabetes. The only side effects of the drug were mild vomiting, nausea, and diarrhea that decreased over time.
Some health experts still have concerns about the drug. There is the possibility that there is a link between liraglutide and pancreatitis. In studies with mice, the drug caused benign and cancerous tumors. There is not yet any direct evidence linking the drug to cancer in human users.