February 24, 2010 / 4:19 PM / 9 years ago

UPDATE 1-Glaxo fires off 30-page rebuttal of Avandia claims

* Official response to U.S. Senate finance committee report

* Rejects allegations of concealing safety information

* Says Senate report improperly casts Avandia as unsafe

(Adds detail on Glaxo report, quotes)

LONDON, Feb 24 (Reuters) - GlaxoSmithKline (GSK.L) stepped up the defence of its diabetes drug Avandia on Wednesday with a detailed 30-page response rejecting a critical report by U.S. lawmakers.

The drugmaker said the Senate finance committee report did not present "an accurate, balanced, or complete view" of information about the drug and the company rejected allegations it had concealed safety data (link.reuters.com/bar62j).

A spokeswoman for Glaxo, which issued a press release on Feb. 20 rejecting the committee’s conclusion that Avandia was unsafe, said the lengthy “white paper” was the company’s official response.

“Glaring omissions” in the Senate report included a lack of discussion of the final results of important clinical trials that were assessed by Food and Drug Administration (FDA) advisors, who voted to keep Avandia on the market, it said.

Glaxo also said that criticisms of Avandia by FDA official David Graham were “flawed and unreliable and, most importantly, do not represent the formal opinion of the FDA”.

For more an Avandia, please click on [ID:nN22208216] and [ID:nLDE61K0C8] (Reporting by Ben Hirschler; editing by Elaine Hardcastle)

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