GlaxoSmithKline (GSK)'s Avandia Gets Second Look at Heart Risk by U.S.
4/12/2013 11:52:07 AM
GlaxoSmithKline Plc (GSK)’s Avandia, the best-selling diabetes pill that was pulled off the market in Europe and tightly restricted in the U.S. because of its heart risks, will undergo another regulatory review. The U.S. Food and Drug Administration plans a June meeting to discuss a re-analysis of a 2009 study, known as Record, that found Avandia more than doubled the risk of heart failure, without increasing hospital stays or death from cardiovascular disease. The re-analysis was requested by a previous advisory panel that found the drug should remain available in the U.S. Glaxo isn’t filing any new applications for Avandia or seeking wider use of the medication, Mary Anne Rhyne, a spokeswoman for the London-based drugmaker, said in a telephone interview.