FDA asks experts should Glaxo’s Avandia stay or go

By Lisa Richwine

WASHINGTON, July 9 (BestGrowthStock) – U.S. government advisers
will consider a range of options for GlaxoSmithKline Plc’s
(GSK.L: ) (GSK.N: ) diabetes drug Avandia, including whether the
medicine should be pulled from the market over heart risks,
according to documents prepared for a meeting next week.

The Food and Drug Administration will ask the expert
committee, that meets Tuesday and Wednesday, to weigh other
possibilities that would allow Avandia sales to continue. They
include restricting the drug’s use, beefing up warnings or
removing a strong heart-attack warning added in 2007.

European regulators said on Friday they were launching a
new probe into the safety of Avandia, adding to pressure on the
medicine. [ID:nLDE6680IZ]

The FDA and its expert panel must pore over a mass of
studies that have various strengths and weaknesses and provide
conflicting findings about the heart risk. Some FDA staff have
pushed for the drug to come off the market.

“There is not complete unanimity within the FDA about the
interpretation of these data,” Dr. Janet Woodcock, head of the
FDA’s drugs center, told reporters on Thursday.

The advisory panel’s recommendation will be considered by
the FDA, although the agency usually follows the advice of its
expert panels.

Avandia remains widely used but its 2009 U.S. sales of $663
million made up just 1.5 percent of Glaxo’s total revenue.
Investors are more concerned about potential liability for the
British drug giant if Avandia comes off the market rather than
reduced sales.

Controversy has dogged the drug since 2007 when Cleveland
Clinic researchers linked the pill to a higher heart-attack
risk. An advisory panel that year agreed the data suggested
Avandia may increase the chances of a heart attack for some
patients but said the medicine should remain an option.

At next week’s meeting, the FDA will ask the committee if
Avandia raises heart-attack risk for Type 2 diabetics compared
to other medicines, including Takeda Pharmaceutical Co’s
(4502.T: ) rival pill Actos.

Glaxo says the overall data shows Avandia does not increase
the overall risk of heart attack, stroke or death and it is the
only oral anti-diabetes drug that has been shown to control
blood sugar for up to five years.

“We look forward to presenting these data and participating
in a rigorous scientific discussion” at the panel meeting,
GlaxoSmithKline Vice President Murray Stewart said in a
(Reporting by Lisa Richwine; Editing by Tim Dobbyn)

FDA asks experts should Glaxo’s Avandia stay or go