FDA declines to approve Qnexa
MOUNTAIN VIEW, Calif. Vivus found itself foiled in its efforts to market a drug for obesity as the Food and Drug Administration turned down its regulatory approval application.
The company said Thursday that it received a complete response letter from the FDA for Qnexa (phentermine and topiramate) controlled-release capsules. The agency said the application can’t be approved in its current form and asked for additional study data. The FDA issues a complete response letter to indicate that it has completed review of an application, but questions remain that preclude final approval.
The prospects for the drug’s approval didn’t look good even before Vivus submitted its application, despite the drug showing some promise in clinical trials. In July, an FDA advisory committee voted 10-6 against recommending approval for Qnexa, citing such possible side effects as psychiatric problems and birth defects. Though an advisory committee’s vote does not determine whether the agency will approve a drug, its vote is taken into consideration.
Decision Resources: More patients switch to Onglyza from Merck’s Type 2 diabetes drugs
BURLINGTON, Mass. Many Type 2 diabetes patients who use the drug Onglyza (saxagliptin) switched to that drug from Merck’s Januvia (sitagliptin) and Janumet (sitagliptin and metformin), according to a new report by market research firm Decision Resources.
The report found that 9.3% of patients for whom Onglyza –– made by Bristol-Myers Squibb and AstraZeneca –– was not their first Type 2 diabetes drug had previously used Januvia, while 7.9% had used Janumet. All three drugs belong to the same class, known as DPP-IV inhibitors.
“While about half of physicians we surveyed predict their prescribing of Onglyza will increase over the next two years, and Onglyza has picked up some patient share from Januvia and Janumet, Januvia’s more favorable formulary positioning and noncoverage of Onglyza will remain important hurdles for Onglyza’s uptake,” Decision Resources analyst Kate Sullivan said.
Supervalu encourages healthy lifestyles with diabetes program
MINNEAPOLIS Supervalu on Thursday announced the launch of a comprehensive, whole-store health-and-wellness program called “living healthy with my diabetes.”
The program offers a variety of resources to make life easier for customers living with diabetes, including educational materials, health screening tests, group and individual diabetes education and training programs, medication management consultations, nutrition information, dietary tools, products and other services.
In addition to the resources that will be available year-round, Supervalu will kick off the program with a number of special, limited-time offers between Nov. 7 and Nov. 20 in honor of American Diabetes Month, including free blood-glucose test screenings in selected locations with pharmacies on Nov. 13 and health screenings for A1c, cholesterol and liver function. Supervalu also will conduct “Eating Healthy with Diabetes” store tours guided by specially trained pharmacists and registered dietitians covering such topics as choosing healthier foods, reading Nutrition Facts labels and identifying better-for-you food options.
“Our neighborhood grocery stores are uniquely positioned to be a one-stop solution for people with diabetes,” stated Chris Dimos, Supervalu president of pharmacy operations. “In addition to offering nutritious foods in our grocery aisles, our pharmacists and dietitians can help educate customers, provide personalized training and guide them to the information, products and services they need to maintain a healthy lifestyle. The program is part of our commitment to provide convenient, affordable health-and-wellness solutions to our customers.”