An FDA advisory panel said Thursday that the regulator should greenlight an obesity indication for Novo Nordisk’s GLP-1 liraglutide, with a vote of 14-1 in favor.
Although known to diabetics by the name Victoza, Novo plans to market the GLP-1 as Saxenda if the obesity indication is a go, meaning the firm will not look to leverage the drug’s familiarity, despite being on the market as Victoza since 2009. A new name also means somewhat turning away from an audience overlap, in that weight gain is often a concern that accompanies diabetes medications.
Further, unlike Amgen’s denosumab, which is marketed to women as the osteoporosis drug Prolia, and to men as the drug Xgeva for bone-related issues associated with conditions including prostate cancer, diabetes and obesity do not have the perception as being female- or male-only conditions, which begs the question: why pursue a new name?
Novo spokesperson Michael Bachner told MM&M in a phone interview that it comes down to a few factors, including a difference in dosage—Victoza is a 1.8mg dose for diabetes, but Saxenda is a 3mg dose, so it is “not a new indication for Victoza.” Bachner added that the application for the obesity indication was done through a separate filing with the FDA as opposed to being submitted as an expansion of an already existing indication. He also notes that although the Victoza materials say the injection “may help you lose weight,” it is not indicated for weight-loss and selling as such would go against the FDA’s label.
Novo will not be able to discuss pricing until or if the FDA approves Saxenda for obesity, so it’s too early to compare the cost of diabetes-indicated liraglutide vs obesity-indicated liraglutide, but the dosage difference shows that simply doubling Victoza won’t be an option, since it would exceed Saxenda’s 3mg.
Bloomberg reports that obesity-indicated liraglutide could bring in $556 million in sales by 2018, on top of the $3.2 billion liraglutide wrangles in the diabetes space.