Friday, July 27, 2007
Article in the Wall Street Journal -- FDA to Seek Guidance Over Avandia, by Jennifer Corbett Dooren and Anna Wilde Mathews. Here's an excerpt:
The Food and Drug Administration is concerned about the potential heart-attack risk tied to the widely used GlaxoSmithKline PLC diabetes drug Avandia, and the agency will ask an advisory panel whether the medication should remain on the U.S. market.
In documents made public yesterday in advance of a public meeting set for Monday, FDA officials wrote that they view Avandia's potential heart-attack risk with "considerable concern," despite "somewhat inconsistent findings that complicate the interpretation of the available data." They wrote that "it is also important to place any risk into context of what is known about the risks of other available therapies" -- notably Japan's Takeda Pharmaceutical Co.'s Actos, the only marketed diabetes drug that works the same way as Avandia.
Monday's meeting could be as significant for the Takeda medication as it is for Avandia. In January, Avandia had 51% while Actos had 49% of the U.S. market for their class of drugs, according to a Morgan Stanley research report that cites data from IMS Health. In May, the New England Journal of Medicine published an analysis by Cleveland Clinic cardiologist Steven Nissen linking Avandia to a potential risk of heart attacks. By July 13, Avandia's market share had dropped to 33% and Actos had soared to 67%. Last year, Avandia was Glaxo's second biggest-selling drug with global sales of $3.38 billion, making up 7% of the Brentford, England, company's total sales of $47.63 billion.