Vivus weight loss drug faces FDA panel this week

Jul 13, 2010

(AP) -- Vivus Inc.'s experimental drug Qnexa was effective in cutting weight, the Food and Drug Administration said Tuesday, while acknowledging lingering concerns over the drug's nervous system and psychiatric side effects.

Still, shares of Vivus jumped as the drug edged closer to approval, potentially the first new prescription drug therapy in more than a decade in the burgeoning obesity market.

The FDA raised some concerns in briefing documents posted online on Tuesday about a range of side effects. It said reviewers should take into account rates of depression, memory and concentration lapses, and heart-related issues, among others. The concerns were not a surprise to Wall Street, which has been following development of the drug over the last several years.

A panel of experts is scheduled to review the drug on Thursday, with the FDA making a regulatory decision in October.

"Given two-thirds of adults in the United States are either overweight or obese, weight loss products, such as Qnexa, may have widespread exposure, and the potential for associated safety issues must be considered," the agency said.

Qnexa is the first of several new weight loss drugs to come under FDA review this year and Wall Street has been following its progress through human studies to gauge its potential.

The drug met key goals in several studies, cutting between 13 percent and 15 percent of patients' body weight. But the FDA is concerned about five types of side effects, including heart risks, increased risk of suicide, metabolic issues, and the potential impact on pregnant women.

Vivus, in its own briefing documents, said research showing that 68 percent of adults in the U.S. are overweight indicate a clear medical need for Qnexa.

"Recent data suggest that if current increases in obesity rates continue over the next decade, the health consequences of obesity will negate the gains in health benefits achieved through the reduction in smoking rates," Vivus said.

In morning trading, shares of the Mountain View, Calif., company rose $1.75, or 16 percent, to $12.40, more than doubling from a low of $5.57 last July.

The obesity problem in America underscores the financial potential of any new weight loss drug. But the search for a new drug has faced decades worth of safety issues. A key example includes fen-phen, which was pulled off the market in 1997 because of links to heart-valve damage and lung problems.

Aside from Qnexa, the FDA is set to review Arena Pharmaceuticals Inc.'s lorcaserin in September, while Orexigen Therapeutics Inc.'s Contrave will be the subject of a December panel.

Explore further: More than a quarter of emergency contraceptives in Peru falsified or substandard

5 /5 (1 vote)
add to favorites email to friend print save as pdf

Related Stories

FDA to review first of 3 new weight loss drugs

Jul 12, 2010

(AP) -- Dieters, doctors and investors get their first extensive look at the first of a trio of new weight loss drugs this week. The hope is that the new drugs can succeed where many others have failed: delivering significant ...

FDA weighs approval of psychiatric drugs for kids

Jun 05, 2009

(AP) -- Three blockbuster psychiatric drugs currently approved for adults also appear to work in adolescents, though federal health officials have concerns about exposing younger patients to the drugs' side effects.

FDA confirms benefits of Crestor in more patients

Dec 11, 2009

(AP) -- Federal scientists say AstraZeneca's cholesterol pill Crestor lowers the risk of heart attack, death and stroke in patients without a history of heart disease, though some safety concerns remain.

FDA: Bristol-Myers diabetes drug appears safe

Mar 30, 2009

(AP) -- A potential blockbuster diabetes medication from Bristol-Myers Squibb appears free from heart-related side effects that have plagued similar treatments, federal health officials said Monday.

Recommended for you

Study recalculates costs of combination vaccines

Apr 17, 2014

One of the most popular vaccine brands for children may not be the most cost-effective choice. And doctors may be overlooking some cost factors when choosing vaccines, driving the market toward what is actually a more expensive ...

Drug watchdog urges vigilance in cancer drug theft

Apr 17, 2014

Europe's medicine watchdog urged doctors Thursday to be vigilant in administering the cancer drug Herceptin, vials of which had been stolen in Italy and tampered with before being sold back into the supply chain.

User comments : 0

More news stories

UAE reports 12 new cases of MERS

Health authorities in the United Arab Emirates have announced 12 new cases of infection by the MERS coronavirus, but insisted the patients would be cured within two weeks.

Filipino tests negative for Middle East virus

A Filipino nurse who tested positive for the Middle East virus has been found free of infection in a subsequent examination after he returned home, Philippine health officials said Saturday.

NASA's space station Robonaut finally getting legs

Robonaut, the first out-of-this-world humanoid, is finally getting its space legs. For three years, Robonaut has had to manage from the waist up. This new pair of legs means the experimental robot—now stuck ...