FDA panel recommendation paves way for Novo Nordisk obesity drug approval
- In a 14-1 vote, an FDA panel has recommended a reformulation of Novo Nordisk's type 2 diabetes drug Victoza that uses the active ingredient liraglutide for obesity treatment. The recommendation is based on a study in which 50% of patients lost 5% of their body weight and 22% lost more than 10%.
- If liraglutide receives final approval for treatment of obesity, it will be marketed under the trade name Saxenda.
- Sales of Victoza have grown rapidly in the last couple of years, with 2013 sales up 27% over 2012 sales.
If Saxenda is approved -- and it likely will be, since the FDA generally accepts the panel’s recommendations -- it will become the fifth FDA-approved anti-obesity drug.
The road to approval for obesity treatments over the last several years has been a rough one, largely due to concerns over cardiovascular risks. But has a distinct advantage over other therapies -- there's already four years of data on liraglutide's safety and efficacy for treating diabetes. Some analysts believe that this status quo advantage will also manifest itself in Saxenda sales and bolster Novo's hand despite a growing crop of anti-obesity medications.
The market for obesity drugs has not been the most lucrative, at least so far. Other treatments including Qsymia and Belviq have seen lackluster sales to date. The FDA approved another obesity therapy, Orexigen and Takeda's Contrave, just last week.
- pharmafile.com FDA panel backs liraglutide for obseity