Monday, May 19, 1997
By Steve Usdin
WASHINGTON - The FDA will make a final decision on the marketing
application for Hoffmann-La Roche Inc.'s Xenical obesity drug within a month, according to
James Bilstad, chief of metabolic drugs at the agency.
Bilstad's comment followed a unanimous recommendation for Xenical's
approval last week by the Endocrinologic and Metabolic Drugs Advisory Committee.
Xenical (orlistat), which blocks fat absorption in the large intestine,
would be the first approved diet drug that directly affects the metabolism of food. The
first drug approved for obesity, Redux dexfenfluramine developed by Interneuron Pharmaceuticals Inc. (IPIC, Lexington, Mass.) and marketed by Weyth-Ayerst, suppresses the
desire to eat by increasing the activity of serotonin in the brain.
Panel members suggested that Xenical's label should carry the same
indication that FDA has imposed on Redux: it should be prescribed only for seriously obese
patients, defined as anyone with a body mass index (BMI) over 30 and patients with
co-morbidities and a BMI of 27 or greater.
Although the committee was impressed by the fact that Roche provided
two years of positive data, and demonstrated a positive impact of Xenical on
co-morbidities of obesity, the drug is unlikely to be widely