Diabetes Drug Avandia to Undergo Regulatory Review: FDA
The U. S. Food and Drug Administration is reviewing the safety of the popular drug Avandia from GlaxoSmithKline used to treat type 2 diabetes. Avandia was pulled off the market in 2010 by the authorities as it upped the risk of heart disease.
According to reports, a joint meeting will be held on the 5-6 June by the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to examine the results of an independent readjudication of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial.
"We welcome the opportunity to update the U.S. Food and Drug Administration about completion of these post-marketing requirements related to Avandia," Mary Anne Rhyne, a spokeswoman for the London-based drugmaker, was quoted in the Businessweek. "GlaxoSmithKline stands behind the safety and efficacy of Avandia when used appropriately and according to its label."
The company paid a penalty of more than $3 billion to resolve the claims stating it illegally marketed Avandia, according to Businessweek.
There are some restrictions on the sale of the drug in the U.S. Patients have to sign a waiver stating they are aware of the risks.
Avandia saw an annual sales figure of about $3 billion once. Last year the drug saw sales worth $1.9 million, according to the data from market analyst IMS Health show.
The drug was initially approved in 1999 and became the most popular drug to treat diabetes by 2006.