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US FDA staff questions Glaxo’s weight-loss drug

January 20, 2006

WASHINGTON (Reuters) – Early evidence shows labeling
proposed to sell GlaxoSmithKline’s weight-loss drug Xenical
over-the-counter may not lead to safe use, U.S. regulatory
staff said in documents released on Friday.

One study showed that some diabetics and other patients who
are not supposed to take the drug, a low-dose alternative to
Roche Holding AG’s prescription version of Xenical, did not
understand the risk after reading the label, U.S. Food and Drug
Administration staff reviewers said.

FDA staff said nonprescription Xenical helped more patients
taking the drug for six months lose weight compared to those
taking a placebo. It was not as effective after four months,
they said, citing company data.

The documents were released ahead of an FDA advisory panel
meeting scheduled for Monday to discuss whether or not the
agency should approve the nonprescription drug.

Shares of Glaxo, which acquired the U.S. rights to market
the both versions of Xenical from Roche last year, were down 19
cents to $50.56 a share in early morning trading on the New
York Stock Exchange. In London, its shares were barely changed.

Xenical, also known as orlistat, helps prevent fat from
being absorbed by the body, but can cause excess gas and oily
discharge.

It can also lead to hepatitis, gallstones and kidney
stones. In their review, FDA staff noted these potential safety
concerns, adding that it was still unclear how Xenical causes
such problems.

The documents were posted on the FDA’s Web site at

http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4201B1-inde

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Source: reuters



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