FDA approves highly anticipated weight-loss pill
The agency also said patients with recent or unstable heart disease or stroke aren’t good candidates for the drug because its effect on heart rates in those patients is not known. Vivus has to do studies of the heart effects of Qsymia, the FDA said.
Analysts estimate the new pill could garner more than $1 billion in sales by 2016, though Mountain View, Calif.-based Vivus Inc. plans a slow rollout.
The pill will launch in the last quarter of the year with a relatively small sales force of 150 representatives. Company executives say their initial marketing efforts will focus on obesity specialists, not general doctors.
“We’re going to have to grow our sales organization in order to support the primary care market,” said Vivus president Peter Tam, in an interview with the Associated Press.
Vivus had originally planned to market the drug under the brand name Qnexa. However, FDA regulators ordered the company to change the name to avoid potential confusion with similar sounding drugs.
Rival Arena Pharmaceuticals Inc. of San Diego plans to start selling Belviq in early 2013. A third California drugmaker, Orexigen Therapeutics Inc., is still running clinical trials of its product, Contrave, and is working toward an FDA approval date in 2014.