As expected, the US Food and Drug Administration is removing certain restrictions that were placed on GlaxoSmithKline’s controversial diabetes drug Avandia.
Avandia (rosiglitazone) was the subject of an unfavourable meta-analysis in 2007 which linked the drug to cardiovascular problems and led to the FDA strictly limited access in 2010; Europe’s regulator banned the drug outright. However, the US agency is now acting on results from the RECORD trial which compared heart attack rates in patients taking Avandia versus metformin and sulphonylurea.
The findings showed no elevated risk of heart attack or death in patients being treated with Avandia when compared to the other drugs. and the FDA says the data do not confirm the signal of increased risk of heart attacks found in the aforementioned meta-analysis. The lifting of restrictions is line with recommendations made by an FDA joint advisory committee in June.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said that the move reflects “the most current scientific knowledge about the risks and benefits of this drug”. “Given the RECORD results, “our level of concern is considerably reduced”, she added, and following changes to the drug’s risk evaluation and mitigation strategy (REMS) programme, Avandia’s use will no longer be limited to certain patients.
The FDA has also told GSK it does not need to conduct a study comparing Avandia to Takeda’s Actos (pioglitazone), the only other approved drug in the thiazolidinedione class. Such a trial “is no longer necessary or feasible”, the agency stated.
GSK said it welcomes the decision “and appreciates the agency’s robust review of the science,” and the company has always stated that Avandia is a safe and effective treatment when used appropriately. However, lifting the restrictions on the drug is unlikely to have any impact on sales as GSK has not promoted Avandia for some time; in June, the company noted that less than 3,000 patients in the the USA were taking the drug which lost patent protection in 2011.
