FDA Does Not Approve New Diet Drug - Qnexa

July 15, 2010 - The U.S. Food and Drug Administration did not give the expected nod of approval to the obesity drug Qnexa, made by Vivus, a California biotechnology company. The FDA panel voted against approval by a margin of  9-7.  In a statement after the meeting, Vivus said the panel's vote was disappointing. The company had been expecting the FDA's approval decision by Oct. 28.

The first new prescription weight-loss pill in more than a decade failed to win backing from U.S. health advisers, who said safety concerns about the drug outweighed its ability to help obese patients shed pounds. FDA advisers expressed concern the once-a-day pill could cause depression, memory-loss and potential birth defects if used among millions of overweight or obese Americans.

Their decision stunned investors, who had more than doubled the share price of the California biotech in the last year on hopes that safety woes would not keep the drug from market.

Reuters reported that: "Even an FDA official was surprised. "When you listen to even the no votes, you got the sense that a lot of people, they weren't strongly against the drug," said Eric Colman, deputy director of FDA's division that oversees such drugs..

Arena Pharmaceuticals (lorcaserin) and Orexigen Therapeutics are also working on obesity drugs and are hoping to gain approval toward the end of the year.

Approving the drug would be "a huge public health experiment," said panelist Elaine Morrato of the University of Colorado, one of the 10 panelists who urged against FDA approval. Six others supported the drug. The FDA will weigh the vote before making its final decision and usually follows its panelists' advice.

Cowen and Company stock analyst Ian Sanderson said it was possible for Vivus to eventually win U.S. approval, but it would first have to test it in as many as 10,000 patients, at a potential cost of $150 million.

Vivus is seeking the FDA's green light with the hope of beating Arena and Orexigen's rival diet drugs to market. It told FDA's outside experts that Qnexa helped many patients shed 35 to 40 pounds and that its risks were not major.

There is little doubt the drug works, panelists said, but potential side effects such as depression, memory loss, increased heart rate and birth defects were a top worry. Panelists were also concerned since patients may take Qnexa for years, but Vivus' data only covered about 12 months. Vivus has said it expects data from a longer, 2-year study by the end of this quarter.

Some analysts saw hope for Arena's candidate, lorcaserin, which tentatively faces FDA's advisers Sept. 16 and has 2-year data. Orexigen's FDA panel is expected Dec. 7.
 

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