The company’s efforts will focus on the recent FDA-approved label change, based on a landmark four-year study, indicating that weight loss with Xenical (orlistat) reduces the risk of developing type 2 diabetes in obese patients with impaired glucose tolerance.
The effect of Xenical plus a low-fat, reduced-calorie diet in reducing the risk of type 2 diabetes was confirmed in the landmark study, called XENDOS. The study showed that patients who experienced weight loss by taking Xenical and eating a reduced-calorie diet lowered their relative risk of developing type 2 diabetes by 37%, compared to placebo and diet.
“Extensive research shows that excess weight is a primary risk factor for the development of type 2 diabetes, which we know leads to an increase in morbidity and mortality,” said Dr David Kelley, director of the Obesity and Nutrition Research Center, department of internal medicine, University of Pittsburgh. “With the 57% increase in the prevalence of type 2 diabetes over the last decade, the long-term use of Xenical is an important tool for clinicians caring for overweight and obese patients.”
In addition to promoting prescription Xenical, GSK Consumer Healthcare is planning to file an application in mid-2005 with the FDA to sell an over-the-counter (OTC) version of orlistat. If approved for OTC sale, orlistat will become available for adults as a weight-loss aid with a different dosing regimen and will be marketed under a separate brand name.
Roche and GlaxoSmithKline were among the first to adopt co-promotion in the US in the 1980s with Zantac. In June 2004, the parties entered into a licensing agreement for Xenical OTC in the US. In addition to expanding this relationship to include prescription Xenical, the parties are jointly developing and co-promoting Boniva (ibandronate) for the treatment of osteoporosis.