FDA Approvals of 2012

13 of 39


Drug: Belviq
Generic molecule: lorcaserin hydrochloride
Company: Arena Pharmaceuticals
Approval date: June 27

The scoop: Belviq is the first weight-loss drug to be approved in more than a decade. It was a long time coming and with the approval the work is not over for Arena Pharmaceuticals ($ARNA). While some analysts see Belviq hitting $1 billion in sales, Arena has to convince doctors that drugs are the way to go in weight loss and payers that they should cover it, particularly since the drug has potential for abuse. Also the data for Belviq was not terribly compelling. The FDA found that patients lost 3% to 3.7% of their body weight and kept it off for a year. That amounts to just over 11 pounds max for a 300 pound person. Also, Belviq almost immediately faced competition from Vivus' ($VVUS) Qsymia.