MORE than 130 million overweight Americans will soon be able to buy a new diet pill in high-street drug stores if regulators approve a filing by GlaxoSmithKline.

Britain’s biggest drug company has asked the Food and Drug Administration to license a low-dose version of Xenical. If the application is successful, GSK will become the first drug company to market an FDA-approved over-the-counter pill for weight loss.

A spokesman for GSK said yesterday that the group hoped to launch the drug by June next year, provided it encountered no last-minute glitches with regulators.

The move comes after the pharmaceuticals giant tested a 60-milligram version of Xenical, which stops the gut from absorbing fat, on patients in a specially designed trial.

In the trial, one in three dieters taking the pill over a four-month period lost more than 5 per cent of their starting weight, while more than half lost over 3 per cent of their initial weight. Volunteers also recorded lower cholesterol levels and fewer problems with blood pressure, GSK said.

James Anderson, professor of medicine and clinical nutrition at the University of Kentucky, said that he was delighted with the results: “The number of overweight individuals in America continues to increase each year and the risk of these folks progressing to obesity is significant.”

GSK believes that many Americans who might be reluctant to go to their doctor for a prescription drug are likely to try an over-the-counter version. The company said that the pill would be packaged as part of a programme which would also contain dietary advice and an exercise regime.

The US Department of Health and Human Services estimates that more than 130 million Americans are overweight or obese. Officials use a benchmark called the body mass index (BMI): those with a BMI ranging from 25.0 to 29.9 are defined as overweight while those over 30 are diagnosed as obese. Weight problems can lead to heart disease, type 2 diabetes and high blood pressure.

Regulators are likely to consult outside experts before deciding whether or not to approve Xenical for over-the-counter use.

The FDA is also expected to make a decision on a new prescription treatment under development by Sanofi-Aventis in the first quarter of next year. The drug, rimonabant, is designed to block a chemical in the body that is believed to be linked to both weight gain and smoking.

In the UK, Phytopharm, a Cambridgeshire-based drugs developer which specialises in making medicines from plant extracts, has signed a deal with Unilever to develop a slimming aid. The treatment is made from Hoodia gordonii, a bush plant that South African bushmen have used for centuries to stave off hunger during long hunting trips.

Shares in GSK dipped 10p to close at £14.45 in thin trading yesterday.

WIGHING UP ANTI-OBESITY DRUGS

Xenical (orlistat)
Made by GlaxoSmithKline; blocks absorption of fat in the intestine. The fat is then excreted instead. First treatment not to rely on suppression of appetite

Reductil (sibutramine)
Made byAbbott Laboratories; makes brain think that the stomach is fuller than it is, stifling appetite

Acomplia (rimonabant)
Made by Sanofi-Aventis; targets receptor in the brain, in fat cells and in other parts of the body to regulate food intake (not yet launched)

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