Vivus Weight-loss Drug Faces Key U.S. Test

GAITHERSBURG, Maryland (Reuters) – Vivus Inc, anticipating to move to marketplace the initial new medication diet drug in some-more than a decade, told U.S. healing advisers on Thursday which its weight-loss tablet gives patients a protected choice for shedding pounds and mending their health.

Vivus is seeking Food and Drug Administration await to sell its drug, Qnexa, to adults to use once a day, along with practice and diet changes, to slim down. But initial it contingency infer its tablet dodges side goods which have sidelined past products.

The stakes are outrageous for Vivus and its investors, who have pushed the batch up some-more than 130 percent in the past year, drawn by the intensity for outrageous sales to millions of overweight Americans. (http://link.reuters.com/vup37m)

The FDA's row of outward advisers will import Vivus' interpretation prior to determining after on Thursday either to behind the drug. The FDA will import the advisers' letter of reference prior to creation its final decision, approaching by Oct 28.

FDA staff mostly await the efficacy of Qnexa, the initial of 3 intensity new diet drug up for examination this year. But they are endangered about its outcome on fetuses, mental illness and heart rate. Memory detriment and alternative cognitive problems and physique poison changes are additionally vicious issues.

That assessment, expelled in papers progressing this week, was cheered by investors who sent Vivus shares up scarcely 20 percent, betting the reserve concerns were not grave sufficient to keep Qnexa from pharmacy shelves. Trading in the shares was halted Thursday sunrise forward of the FDA advisers' decision.

"The healing need is urgent," pronounced Louis Aronne, a healing highbrow at Weill-Cornell Healing College who addressed the advisers on interest of Vivus. "It's transparent which we need new healing therapies to conduct the widespread of obesity."

If approved, Qnexa would suggest a intensity fat-fighting jump-start to the some-more than two-thirds of Americans who are overweight or portly -- and would progress a scarcely 20-year-old biotech association which has not had a U.S. product authorized given 1996.

Last year, medication and over-the-counter diet drug took in usually $381.5 million, according to IMS Health.

If Qnexa wins a immature light from FDA, which figure could soar. Analysts guess Vivus' drug could take in scarcely $689 million in sales by 2014, according to accord foresee interpretation from Thomson Reuters.

Current weight-loss drug have not gained many traction, as many usually trim a few pounds but lift vicious or upsetting side goods such as heart risks or gas.

'FOCUS ON SAFETY'

"In general, the FDA is in agreement with the association with apply oneself to the weight-loss goods of the drug," pronounced Eric Coleman, emissary executive of the FDA multiplication which oversees metabolic drugs. "The concentration is essentially on safety."

The drug's intensity to means inborn defects in unborn babies is a sold concern, generally given women of childbearing age are the pill's aim customer.

So far, analysts have been assured about Vivus' capability to strike reserve hurdles.

"The vicious cause in seeking at the interpretation is the huge good which (Qnexa) provides," pronounced Ira Detriment of Washington Analysis Corp, who follows the FDA for monetary clients. "The risks are not insurmountable. They can be managed."

Qnexa attempts to urge on the barbarous "fen-phen" diet drug. It combines one of fen-phen's mixture -- the ardour suppressant phentermine -- with the anti-seizure drug topiramate. Fen-phen's alternative ingredient, fenfluramine, was pulled off the marketplace in 1997 when vicious heart valve problems emerged.

Patients receiving Qnexa saw in between 3 percent and 9 percent weight detriment over placebo, depending on how many of the drug they took, FDA staff pronounced in a memo on Tuesday. Patients additionally saw softened red red blood pressure, and improved fats and sugarine levels in the blood.

Industry watchers and Vivus competitors will additionally be examination the advisers' assembly for clues on the FDA's meditative forward of identical reviews final this year of two opposition drugs, from Arena Pharmaceuticals and Orexigen Therapeutics, whose shares have additionally soared.

Diet pills already on the marketplace embody Abbott Laboratories' Meridia, which carries multiform heart-related risks, and Roche Holding AG's Xenical, which causes liver problems and rash bowel movements.

"Imagine what a drug can do which doesn't have side goods and removes some-more weight," pronounced Leerink Swann researcher Steve Yoo.

FDA capitulation would give Vivus its second U.S. drug given its 1997 launch of Muse, an erectile dysfunction suppository which took in usually $15.8 million in net U.S. income in 2009. The company's efforts to marketplace a passionate dysfunction thick cream for women flopped in 2006. (Reporting by Susan Heavey and Jonathan Lentz; one more stating by Susan Kelly in Chicago; Editing by Bernard Orr and John Wallace)

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