FDA is reviewing new data and reports on the safety of GlaxoSmithKline's blockbuster diabetes drug Avandia, and will present findings at a public meeting this summer.
Discussions over the drug's cardiovascular side effect were reignited last weekend after internal FDA reports expressing concern about Avandia surfaced in the New York Times
, in addition to a report from Sens. Max Baucus (D-MT) and Chuck Grassley (R-IA) that examined internal GSK communications, FDA documents and other materials beginning in May 2007.
According to Baucus and Grassley's report
, GSK sought to suppress negative findings about Avandia's side effects – from intimidating independent physicians to downplaying published studies – since 1999, the year Avandia was approved. The report also contains statements made by two FDA officials – David Graham and Kate Gelperin – that rosiglitazone, the active ingredient in Avandia, should be “removed from the market.” GSK issued a statement
rejecting the Senate findings.
Sales of Avandia have steadily decreased over the last few years, while sales of Takeda's Actos have increased, based on fewer heart-related side effects. According to IMS Health data, Avandia prescriptions for the year ending in July 2009 were down 28% to 1.6 million. During the same period, Actos had over 8 million scripts filled, earning $1.7 billion. Avandia will begin losing some patent protection in 2012. According to FDA's Orange Book, Actos will hold a majority of its patents until 2016.
Advertising materials for Takeda's Actos (pioglitazone) have targeted Avandia's safety risks in the past. In November 2007, just days after Avandia picked up a second black box warning, Actos launched a print campaign touting the drug's ability to ”lower blood sugar without increasing your risk of having a heart attack or stroke.” Calls to Takeda about any new advertising materials were not immediately returned.