Vivus’s experimental diet pill Qnexa helps lower blood pressure and cholesterol. Once-daily Qnexa helped reduce dependence on blood-pressure pills by as much as 19 percent on average and decrease triglycerides by 26 percent, according to research presented yesterday at the American College of Cardiology meeting in New Orleans. No new safety risks were found among 675 overweight and obese patients in the study, called Sequel. The results may prompt U.S. regulators to approve the medicine.
The Food and Drug Administration declined to approve Qnexa in October partly because of concern 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 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 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.
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.
Future of Diet Pills
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.
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.