Looks to be impacted again---
"FDA panel backs SmithKline's Avandia for diabetes
WASHINGTON, April 22 (Reuters) - A Food and Drug Administration panel on Thursday voted to back SmithKline Beecham's (quote from Yahoo! UK & Ireland: SB.L) Avandia to treat adult-onset, or Type II, diabetes.
The panel said it supported Avandia for use as a stand alone therapy and in combination with another diabetes drug, metformin.
Earlier on Thursday, FDA officials agreed with SmithKline Beecham that Avandia did not appear to cause significant liver problems like those associated with rival drug Rezulin made by Warner-Lambert Co. (WLA - news). Warner-Lambert and the FDA said Rezulin has been linked to 28 cases of death from liver failure.
Analysts have said Avandia, known generically as rosiglitazone, could be a blockbuster in the huge Type II market, estimated at about $4 billion last year.
The drug belongs in a class known as TZDs, or glitazones, that work by helping insulin remove glucose from the bloodstream.
More than one million people have taken Rezulin, which produced dramatic improvements in some patients fighting Type II diabetes, which afflicts about 15 million Americans and can lead to serious complications such as blindness and limb loss." |