Weight-Loss Drug Qnexa Review Delayed By Late-Arriving REMS

The FDA is delaying its action goal date on Vivus’ obesity drug Qnexa to July 17 after the company’s late submission of a risk evaluation and mitigation strategy (REMS). The agency originally had a deadline of April 17. While the FDA will likely approve the drug, an extra 90 days could leave room for a new safety issue or argument to derail the agency’s intentions, Cowen analyst Simos Simeonidis said Tuesday.
Washington Drug Letter