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Roche seeks further FDA approval for diabetes drug

Roche seeks bigger market in United States

(Keystone Archive)

The Swiss pharmaceutical group, Roche, is to ask the United States Food and Drug Administration (FDA) to approve its Xenical anti-obesity drug for use in the treatment of Type II diabetes.

The FDA has already approved Xenical as a treatment for obesity, and Roche hopes the drug will soon be able to be used in combination with other anti-diabetic medications for treating Type II diabetes, which is caused by obesity.

"Approval provides an additional market opportunity for Xenical in the US, where it is already approved for weight management in patients who are overweight or obese," Roche said in a statement.

Xenical is a unique weight management treatment that acts locally by preventing fat from being absorbed in the gut.

Roche said clinical studies have shown that Xenical patients had experienced significant improvements in blood sugar control. It said this enabled patients to either reduce the amount of anti-diabetic drugs they need to take, or in some cases to discontinue the medication altogether.

"Type II diabetes is a major global public health problem with the incidence and prevalence of diabetes escalating towards a world-wide epidemic," Roche added in its statement.

In the US, the number of cases of Type II diabetes increased by a third between 1990 and 1998. Many other countries have reported similar rises and it has been estimated that, globally, almost 300 million people could have Type II diabetes by 2025.

swissinfo with agencies


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