Drugmaker Readies Fat-Blocker Spots
Xenical is already marketed in Europe, the Far East and Latin America. Sales levels internationally totaled $725,900 in the fourth quarter of last year.
The drug is one of a new class of fat-blocking agents that prevents fat absorption in the gastrointestinal tract, unlike phen-fen which worked on the central nervous system of the brain and was banned from sale in 1997.
"It [Xenical] is an extremely safe product," said Jim Sandino, managing director of Lowe & Direct, the New York ad agency that will market the drug with a DRTV promotion. Sandino said he could not discuss the commercial until Hoffman-LaRoche received final approval from the FDA.
"We feel very confident about the product and that we will get the FDA approval," he said. "It has been proven that you can get modest weight loss through Xenical but some people have done very well with the product."
He added that he did not want to give any information about the drug to competitors.
Hoffman-LaRoche officials said Xenical offers obese patients a "real" opportunity to lose weight and the ability to keep it off. Xenical contains orlistat, which combined with dieting promotes weight loss, lessens the amount of weight regained and improves disease risks associated with obesity.
Incidences of breast cancer among people participating in the studies were discovered in 1997. Hoffman-LaRoche withdrew its original application in August of that year to complete the an analysis required by the FDA to ensure the drug was not the cause of the cancer.
The application was resubmitted in November 1997 and received the backing of the advisory committee last month.
"It is hard to be sure about drugs these days," said Dr. Robert Rutledge, a gastrointestinal specialist at the University of North Carolina Hospital. "Although a few patients came out with breast cancer, more of the side effects effected bowel movement. The group wanted to make sure that the cases of breast cancer were not related to the drug. It was very disconcerting to them."
The FDA would not comment further on the status of the application for approval. n