September 10, 2014
By Mark Terry, BioSpace.com Breaking News Staff
The U.S. Food and Drug Administration announced it had published briefing documents ahead of the September 11, 2014 Advisory Committee meeting regarding the Denmark pharmaceutical company Novo Nordisk ‘s obesity drug Saxenda® (liraglutide). The FDA provided preliminary assessment by reviewers, indicating that the drug seemed to be effective in treating obesity, but that its safety was still under review. Specifically, there appeared to be higher numbers of breast malignancies in women who took the drug, but that the available data was not conclusive.
Liraglutide has been approved to treat Type 2 diabetes and is marketed under the name Victoza. The drug is a GLP-1 analog, which apparently fights obesity by slowing the movement of food from the stomach.
In the study, 3,731 overweight or obese individuals were randomized for treatment with liraglutide or a placebo, both in combination with diet and exercise. Individuals without indications of prediabetes were treated for 56 weeks, followed by a 12-week follow-up period. People who had signs of prediabetes continued the treatment for two more years. Of the 61 percent of participants with prediabetes, at the 56-week mark, 69 percent of that subgroup treated with liraglutide no longer showed signs of prediabetes compared to 33 percent of the placebo group. For patients without prediabetes, the number that developed prediabetic symptoms (7%) was significantly lower than those in the placebo group (21%). In addition, people treated with the drug showed statistically significant improvements in blood pressure, cardiovascular risk biomarkers, lipids, and patient-reported quality of life.
The FDA will review liraglutide on Thursday. As a diabetes drug, it generated slightly over $1 billion in revenue in the first six months of 2014, and around $2 billion in 2013. GLP-1 analogs come with some concerns, http://www.mmm-online.com/novo-seeks-liraglutide-obesity-indication/article/370567/ including risks of pancreatitis, although European and U.S. agencies indicate there is not enough data to link the drug class to pancreatic cancer. There are a number of GLP-1 analogs currently on the market, including AstraZeneca’s Bydureon® and Byetta® (exenatide) and GlaxoSmithKline’s Tanzeum® (albiglutide). Eli Lilly’s dulaglutide may also provide competition. Not yet on the market, dulaglutide didn’t show that it was more effective than Victoza in a clinical trial, but analysts still think it could create sales of $1.5 billion by 2020.
As a result of the announcement, Novo Nordisk’s stock rose 1.8 percent to 262.70 Danish kroner. Should it receive FDA approval on Thursday, analysts suggest it could jump another 2 or 3 percent. A negative outcome, however, could cause the stock to drive by 5 percent or more.
