FDA PANEL RECOMMENDS APPROVAL FOR OTC WEIGHT-LOSS DRUG
GlaxoSmithKline (GSK) moved one step closer to marketing it anti-obesity drug Xenical without a prescription after an FDA advisory panel late Monday overwhelmingly recommended the agency approve the company's application to sell the drug OTC.
The agency's Nonprescription Drugs Advisory Committee and Endocrinologic and Metabolic Drugs Advisory Committee voted 11-3 in favor of GSK's bid for OTC Xenical (orlistat). The FDA is not required to follow the advice of its advisory committees, but usually does.
Xenical would be the first FDA-approved weight-loss drug available in the U.S. without a doctor's prescription. GSK would market the drug under the name Alli.
"We are encouraged by the committee's recommendation for approval of what would be the only FDA-approved safe and effective OTC weight-loss aid for overweight adults," George Quesnelle, president of GSK Consumer Healthcare North America, said after the committee's decision.
But advocacy groups such as Public Citizen have opposed the OTC switch, arguing that Xenical had only minor benefits in relation to a variety of risks. The drug can prevent the body from absorbing certain vitamins, cause gastrointestinal adverse reactions, and may have negative effects on patients with Type 2 diabetes, hypertension or dyslipidemia, Public Citizen said.
In light of these issues, switching the drug to OTC status would be a "serious, dangerous mistake," said Sidney Wolfe, director of Public Citizen's Health Research Group. The group is planning to contact the agency to express its concerns with the advisory committee's decision, adding details as to why this is a bad move, Wolfe told FDAnews.
Developed by Roche, Xenical has been available by prescription in a 120-milligram dose since 1999. The product generated sales of roughly $497 million in 2004. GSK acquired the rights to nonprescription Xenical in July 2004 when Roche divested its OTC drug division. (http://www.fdanews.com/did target=_blank)