WASHINGTON. A new prescription weight-loss pill — the first in more than a decade — helps people shed pounds, U.S. regulatory staff members said. But they are still concerned about potential safety issues.
Analysts largely shrugged off the Food and Drug Administration’s concerns and shares of Vivus Inc. (maker of Qnexa) jumped more than 15 percent yesterday after the agency’s staff said the experimental drug appeared to work.
Tomorrow, an FDA panel of outside experts will discuss safety issues and offer advice on whether to approve Qnexa. The agency will then make the final approval decision, expected by October 28.
The biotechnology company wants to market the once-a-day pill for use with diet and exercise. If approved, it would be the first new U.S. prescription weight-loss drug in more than 10 years.