Sponsorship Link
Shares of Vivus Inc. more than doubled early Thursday after a U.S. FDA advisory panel recommended the agency approve the company's new weight-loss drug Qnexa.
Vivus jumped $9.45 to $20, leading other diet-drug developers such as Arena Pharmaceuticals and Orexigen Therapeutics higher. Qnexa is one of three drugs competing for the first U.S. approval of a prescription weight-loss drug since Roche's Xenical in 1999.
/
Qnexa FDA Approval of First Weight-Loss Pill in 13 Years Watch Video
Related Articles
Search Senior Housing Facilities
Create a personal senior housing list with our search. Search Nursing Homes to find U.S. News-rated facilities. For other types of senior housing, you can access Seniors for Living's list of thousands of additional facilities.
Enter location
| or |
Selecting housing type
Data so far indicates the drug is the most effective in helping patients lose up to 10 percent of their body weight, ABC News said.
The FDA isn't required to follow the panel's recommendations, although it generally does. An official approval or a rejection of Qnexa is expected by April 17. The panel voted 20-2 vote for approval, saying Qnexa's benefits for the chronically obese outweighed potential risks the drug may pose, according to ABC News.
Must Read
Qnexa was presented before the advisory panel in 2010, but it recommended against the drug 10-6 before the FDA rejected it for further testing, according to The New York Times.
Follow us
Here are some things to know about Qnexa.
Meaningful Efficacy Benefit
"There is an urgent need for better pharmacologic options for individual patients," Elaine H. Morrato, an assistant professor at the University of Colorado, Denver, told The NYTimes.
"I believe that Qnexa demonstrated a meaningful efficacy benefit and that there are consequences to nontreatment of obesity," she said. Morrato voted against the drug in 2010 but voted in approval of it on Wednesday.
Qnexa is a combination of two drugs - phentermine, which is a stimulant, and topiramate, an epilepsy and migraine drug - also known by the name Topamax.
The Times reported that use of Qnexa led to an average weight loss of approximately 10 percent body weight after one year. However, some of that lost weight was gained back in the second year of use.
Qnexa also reportedly helped lower both blood pressure and blood sugar, improving users quality of life.
Vivus is expected to market Qnexa to those who meet the government's obesity standards, which is calculated at a body-mass index of 30 or greater. The labeling will include instructions stating that those who lose less than three percent of their body weight in three months should stop taking the drug, reported WebMD.
One-third of Americans are obese. This has been linked to high blood pressure, diabetes and other serious health problems. It has also saddled the healthcare industry with billions of dollars in healthcare treatment.
