FDA Panel's Vote Over Weight-Loss Drug Xenical Results in Tie 

March 16, 1998
BASEL, SWITZERLAND

 Xenical: Prices and Ordering Information

The United States Food and Drug Administration's endocrinologic and metabolic drugs advisory committee is deadlocked at five to five on recommending approval of F. Hoffmann-La Roche Ltd.'s weight management drug Xenical(R) (orlistat).

Roche said it would meet shortly with the FDA staff to discuss the recommendation. Roche reaffirms its belief that orlistat has an important role to play in the management of obesity and looks forward to discussing next steps with the FDA.

In May 1997 the panel unanimously recommended the approval of Xenical, a lipase inhibitor which acts in the gastrointestinal tract to decrease fat absorption by about 30 percent. Drugs in this class do not achieve their effect through brain chemistry.

Previous studies showed that Xenical-treated patients had statistically significant reductions in total and LDL cholesterol and systolic and diastolic blood pressure, as well as improvements in blood concentrations of glucose and insulin after one year over placebo with diet.