Memorandum

Novo Nordisk announces September 11th FDA Advisory Committee meeting for liraglutide 3 mg for obesity – May 21, 2014

Yesterday, Novo Nordisk announced that the FDA has tentatively scheduled a September 11 Advisory Committee meeting for liraglutide 3 mg for obesity - the date is just under nine months after the drug was filed on December 20, 2013. Very recently, at AACE Day #3, we saw full results from the SCALE Obesity and Prediabetes phase 3 study, which demonstrated placebo-adjusted weight loss of 5.4% with liraglutide 3 mg (8.0% with liraglutide, 2.6% with placebo). Approximately 63% of patients on liraglutide achieved weight loss of at least 5% vs. 27% for placebo. Later at AACE Day #4, Dr. Alan Garber (Baylor College of Medicine, Houston, TX) characterized liraglutide 3 mg as perhaps the most effective monotherapy for obesity on the near-term horizon or on the market (Vivus' Qsymia is a combination of two agents). Very notably, patients on liraglutide experienced a higher incidence of gallbladder disorders (2.7 events/100 patient-years of exposure [PYE] vs. 1.0 events/100 PYE with placebo) and acute pancreatitis (0.3 events/100 PYE vs. 0.1 events/100 PYE with placebo). Gall bladder disorders are generally associated with weight loss, and so that signal could just be linked with the greater weight loss seen in the liraglutide arm. Although the majority of pancreatitis cases were mild and improved quickly upon drug discontinuation, Novo Nordisk is investigating these findings further - we note that while the imbalance in acute pancreatitis is potentially worrying, the real question is whether this increase leads to an increase in pancreatic carcinoma. In any event, we expect a very in-depth discussion at the Advisory Committee meeting, as all Advisory Committees are.