May 24, 2007
GSK CEO Garnier says data will ‘vindicate’ Avandia
GlaxoSmithKline CEO Jean-Pierre Garnier said forthcoming Avandia safety data could help the drug regain sales it may potentially lose due to safety concerns currently swirling around the diabetes treatment.
Analysts said they expect sales of Avandia to drop sharply in the wake of an article appearing in The New England Journal of Medicine ( NEJM ) Monday stating patients taking the drug have a 43% greater risk of heart attack than those using other diabetes drugs or no medication.
GSK said its own reviews of Avandia show the drug increased heart attack risk by 30% and that it told the FDA about it last year.
The Associated Press reported Garnier acknowledged at a company shareholders meeting on Wednesday that sales of Avandia could fall and that it’s too early to predict whether the drug will be the target of product liability lawsuits.
“We expect that once the complete data set on Avandia becomes available, our product will be vindicated,” Garnier said.
Avandia was approved in 1999 for treatment of Type 2 diabetes, a disease that affects about 18 to 20 million Americans. GSK’s Avandia/Avandamet franchise had global sales of $3.2 billion for 2006.
An FDA panel is due to meet to examine safety data on Avandia, following the NEJM study.
“We are looking forward to this meeting,” Garnier said.