Novo Nordisk ($NVO) convinced a group of FDA advisers that its liraglutide, already a blockbuster diabetes treatment, can effectively combat obesity, clearing the way for a second indication that could add $1 billion to its annual sales.
The panel voted 14-1 that Novo's pivotal data support full approval for a 3 mg injection of the drug, which is marketed at lower doses as the diabetes-treating Victoza. The advisory committee ruled that liraglutide's benefits outweigh its risks, pointing to Phase III data in which about 60% of the obese patients reduced their body weight by at least 5%, and nearly one-third of them shed more than 10%.
Now it's up to FDA staff whether to grant liraglutide its second approval, and a final decision is expected by Oct. 20. The agency is not beholden to follow the votes of its advisers, though it commonly does.
If approved for obesity, Novo plans to market its 3 mg shot as Saxenda, and analysts have said the new indication could heap another $1 billion a year onto liraglutide's sales at its peak. Victoza brought in about $2.1 billion for Novo last year, growing 27% over 2012.
But the recent history for weight-loss drugs suggests Saxenda is no sure bet. In 2012, Arena ($ARNA) and Vivus ($VVUS) won FDA nods for new obesity pills with similarly starry-eyed projections, but safety concerns and payer disinterest led to disappointing launches, and both companies have struggled to gain any market traction. On Thursday, Orexigen ($OREX) picked up FDA approval for Contrave, its long-delayed weight-loss treatment, but investors worry that the drug's long list of potential side effects will doom it to the same fate. The biotech's shares have slumped more than 10% since.
And liraglutide is not without its own safety concerns. The FDA has an open file on the drug's relationship to pancreatitis, an issue that led advocacy group Public Citizen to clamor for a ban on U.S. sales. Furthermore, in reviewing its obesity application, FDA advisers pointed to a spike in breast malignancies among female patients taking the drug, saying the injection's role in cancer promotion remains an open question.
Liraglutide works by bolstering the hormone glucagon-like peptide-1, which is naturally released after eating and regulates the body's insulin secretion. The treatment binds to GLP-1 receptors and stimulates the release of glucose-dependent insulin while suppressing the release of glucagon, a hormone that raises blood sugar concentration.
|Mads Krogsgaard Thomsen|
"We are pleased with the clear recommendation from the advisory committee," Novo Chief Science Officer Mads Krogsgaard Thomsen said in a statement. "... Obesity is a serious public health issue in the U.S., and we are committed to making Saxenda a new treatment option for adults with obesity."
- read Novo's statement (PDF)