Hmmmm. I know you still think the Vulvo issue has not been put to bed. But why would Arna not at least take the recommendation and do the 12 month rat study? Isn't that just asking for trouble. Maybe Herper is right and Lief needs to go. Seems to me that would be the best idea, especially in light of Contrave's beat down.
Vivus’s Diet Pill Has Heart Benefits That May Support Approval, Study Says By Catherine Larkin - Apr 3, 2011 3:30 PM CT
.Vivus Inc. (VVUS)’s experimental diet pill Qnexa helped patients lower their blood pressure and cholesterol after two years, additional benefits that may help persuade U.S. regulators to approve the medicine.
Once-daily Qnexa helped people reduce their dependence on blood-pressure pills by as much as 19 percent on average, and decrease their triglycerides by 26 percent, according to research presented today at the American College of Cardiology meeting in New Orleans. No new safety risks were seen among 675 overweight and obese patients in the study, called Sequel.
The Food and Drug Administration declined to approve Qnexa in October in part because of concerns that the medicine may cause heart risks and birth defects. Regulators have said they want to see additional benefits of diet pills outside of weight loss to support their approval in a subgroup of patients, rather than all two-thirds of Americans who are overweight.
“Weight loss is important but it’s got to be associated with markers that mean that we’re really making a difference to the patient,” said Michael Davidson, the director of preventive cardiology at the University of Chicago, in a telephone interview. Davidson, a researcher on the Vivus-funded study, presented the data at the medical meeting.
The Mountain View, California-based drugmaker is competing with San Diego-area companies Orexigen Therapeutics Inc. (OREX) and Arena Pharmaceuticals Inc. (ARNA) to introduce the first prescription diet pill in the U.S. in more than a decade. All three products have been delayed by FDA requests for more data.
‘Missing Piece’ The FDA asked for a new study on the heart risks of Orexigen’s Contrave in February, which analysts said may delay its approval by years. Vivus shares dropped 15 percent on the news as investors feared the company would need a similar study.
The new data on blood pressure and cholesterol provide “one of the missing pieces of information” that may help the FDA decide whether Qnexa should be approved, Davidson said.
Vivus said in January that it may need to review existing databases to determine the risk of oral cleft in children whose mothers took topiramate, one of two ingredients in Qnexa. Analysts said at the time the analysis may take as long as six months. Arena must provide the FDA more data on potential cancer risks and effectiveness questions with its medicine, lorcaserin, and plans to reply by the end of the year.
Patient-advocacy groups led by the Obesity Action Coalition met with the FDA last month to discuss the future of diet pills and what data will be necessary to support their approval. Top agency officials want to see drugs that reduce complications experienced by some people because they’re overweight, such as sleep apnea, said Joseph Nadglowski, president of the Tampa, Florida-based coalition, in a telephone interview.
10 Percent Weight Loss Qnexa helped patients lose about 10 percent of their body weight on average in the two-year Sequel study, according to initial findings released in September. Doctors say the drug is the most effective of the three new diet pills.
About 68 percent of American adults are overweight, raising their risk of diabetes, heart disease, high blood pressure and cancer, according to a 2008 National Health and Nutrition Examination Survey. Almost 34 percent are obese, measured as a ratio between height and weight.
Xenical, from Basel, Switzerland-based Roche Holding AG (ROG), was approved in 1999 and is the only long-term prescription medicine for weight loss available in the U.S.
To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net .
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