U.S. advisers back experimental obesity pill
SILVER SPRING, Maryland
SILVER SPRING, Maryland (Reuters) - An experimental obesity drug from Vivus Inc won the backing of a U.S. advisory panel on Wednesday, raising hopes regulators would approve a weight-loss pill for the first time in 13 years.
A panel of outside experts to the Food and Drug Administration voted 20-2 to recommend approval of Qnexa, meant to treat obesity and its accompanying health problems.
The FDA rejected Vivus' Qnexa in 2010 because of safety concerns related to heart rate and birth defects, along with two other obesity pills that are also seeking a second round of consideration.
An advisory committee in 2010 voted 10-6 that safety concerns overwhelmed the benefits of Qnexa.
But this time most panelists were convinced that Qnexa's benefits to treat obesity outweighed its risks, but adding that there should be a post-approval study on heart risks.
Panelist also supported the company's plans to carefully control who gets the drug and limit it to women who are not pregnant. These plans were not part of Vivus's first submission.
"I think everyone around the room knows obesity and its substantial health risks," said Dr. Susan Yanovski, panel member and director of the obesity and eating disorders program at the National Institutes of Health.
"I would say not treating obesity is not risk neutral. We have few treatments for obesity for those who don't respond to lifestyle treatments."
The FDA usually follows panel recommendations, although it is not required to. It will make a final decision by April 17.
Qnexa, which combines the appetite suppressant phentermine and anti-seizure drug topiramate, helped patients lose at least 10 percent of their weight after a year of treatment, the company said.
Obesity, a leading cause of diabetes, heart disease and other serious health problems, has reached epidemic proportions in the United States, with about a third of the population obese and more than half overweight.
The FDA has set a high approval bar for weight loss drugs because such a large portion of the general population is likely to want to take them, and has not approved a new obesity drug since 1999.
Shares of Vivus were halted on Nasdaq on Wednesday pending the outcome of the FDA panel meeting. They closed at $10.55 on Tuesday, well above the stock's low around $4.70 after the pill was first rejected.
(Reporting by Anna Yukhananov; Editing by Tim Dobbyn)