Roche Nearer To Obesity Drug Approval

Roche has moved a step closer to getting its new obesity drug Xenical(orlistat) approved in the USA with a positive recommendation from the US Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee.

Xenical is leading the field amongst a new class of antiobesity drugs, the pancreatic lipase inhibitors, which act in the gastrointestinal tract to prevent the absorption of fat by around 30%. Roche believes that this nonsystemic approach will be an attractive alternative to drugs which act via the central nervous system, including the serotonin reuptake inhibitor Redux (dexfenfluramine) marketed since June 1996 in the USA by American Home Products' subsidiary Wyeth-Ayerst.

Roche presented data to the panel from studies conducted in more than 4,000 patients in the USA and Europe, which indicated that almost three times as many patients on 120mg td Xenical, over one-third of those treated, lost 10% or more body weight compared to placebo. All patients followed a modestly restricted calorie diet (30% of calories from fat). Furthermore, nearly twice as many patients lost at least 5% body weight compared to placebo. As a rule of thumb, the average patient in the studies weighed 100 kilos and lost 10 kilos.