Avandia testing faces new questions

U.S. regulators are reviewing the safety of GlaxoSmithKline P.L.C.'s Avandia diabetes drug as they weigh whether to suspend a trial testing the medicine, Bloomberg News reported.

The Food and Drug Administration is reassessing a study comparing Avandia with a rival medicine from Takeda Pharmaceutical Co., and whether it is ethical to pursue the research after studies tied the Glaxo drug to an increased heart attack risk, according to a letter from FDA Commissioner Margaret Hamburg, dated March 30, the news service said.

An independent data monitoring committee has so far "not expressed any concerns regarding the safety of participants in the study and has recommended that the study continue without modification," Glaxo spokeswoman Claire Brough said today in an e-mail to Bloomberg.

Avandia, which came on the market in 1999, generated annual revenue of $3 billion by 2006, including sales of a combination drug that includes it.

A research note last month by UBS analysts said that GlaxoSmithKline P.L.C. could be facing liabilities of as much as $6 billion from 13,000 personal-injury lawsuits relating to Avandia.

That UBS note followed by a week a highly critical report on the drug by the U.S. Senate Finance Committee. The Senate report criticized GlaxoSmithKline's handling of heart risks with the drug.

The first of two U.S. federal bellwether trials, which will likely provide an indicator of court decisions in other Avandia cases, is due to start June 1 in Pennsylvania.

London-based Glaxo has major operations in the Philadelphia area.    - Inquirer Staff