Zafgen charts unique path to obesity approval

Abstract

capture. In 2012, the US Food and Drug Adminstration (FDA) approved Arena and Eisai’s lorcaserin as well as Vivus’ combination of phentermine and topiramate, the first new obesity drugs to make it to market in years. Yet, sales of these drugs in 2013 were US$25 million and $23 million, respectively. Neither drug was approved in Europe. The difficult-to-tap market is also crowding up. Last December, the FDA approved Novo Nordisk’s liraglutide for obesity. Because the glucagon-like peptide 1 (GLP1) inhibitor was initially developed and approved for type 2 diabetes, its obesity approval was backed by a particularly large set of safety data and patient experience. Novo Nordisk is also expecting a decision from the European Medicines Agency (EMA) on the obesity indication for liraglutide by the end of 2015. In 2014, the FDA and the EMA both also approved Orexigen Therapeutics’ combination of bupropion and naltrexone. The FDA had rejected the combination in 2011 owing to concerns over its cardiovascular safety profile, but Orexigen and its partner Takeda addressed these with interim data from an ongoing cardiovascular outcomes trial. Asher Mullard Zafgen charts unique path to obesity approval