Novo seeks liraglutide obesity indication
An FDA advisory panel is set to review Novo Nordisk's diabetes medication liraglutide for a weight-loss indication
An FDA advisory panel is set to review Novo Nordisk's diabetes medication liraglutide for a weight-loss indication on Thursday and company research supporting the review indicates that clinical-trial patients lost between 5% and 10% of their weight during the 52-week program. Novo teased weight-loss results at an American Diabetes Association meeting over the summer.
Patients across the series of clinical trials that panelists will review were a mix of diabetics and non-diabetics who had either a BMI of 30 or above or BMI of 27 and at least one co-morbid condition. Patients were given a 3mg dose, as opposed to 1.8mg, which is the typical amount for diabetes.
Rising obesity rates would indicate a pent-up demand for weight-loss medications, but physicians and patients are still warming up to prescriptions such as Arena's Belviq (lorcaserin) and Vivus's Qsymia (phentermine and topiramate). Unlike Belviq and Qsymia, liraglutide is an established market brand—Victoza leads the GLP-1 market segment, and garnered just over $1 billion in sales for the first six months of 2014, and around $2 billion for all of 2013.
However, Novo does not plan to leverage this familiarity and expects to market a weight-loss indicated liraglutide as Saxenda.
The new name still comes with concerns that have surrounded GLP-1s, such as an association with an elevated heartbeat, which is not clearly linked to a negative effect. The class as a whole is also associated with concerns about pancreatitis, but both European and US regulators said there was insufficient data to link GLP-1s with pancreatic cancer.
Liraglutide also runs up against the same constraints as any weight-loss regimen, which is that it still requires changes to diet and an activity regimen.
The GLP-1 diabetes category is becoming increasingly crowded, which adds to the significance of garnering an additional indication for liraglutide, since Novo is fighting for attention with on-market treatments including AstraZeneca's Bydureon and Byetta (exenatide) and GlaxoSmithKline's recently approved Tanzeum (albiglutide).
Even Eli Lilly's unapproved dulaglutide poses a threat: ISI analyst Mark Schoenebaum noted in a February research note that dulaglutide poses a threat to Novo's Victoza even though clinical trials do not indicate it is a better treatment. His estimate: Lilly's experimental GLP-1 could sweep one-third of the market, or $3 billion in sales.