An expert committee of the FDA recommended by an overwhelming margin that GSK's Avandia should stay on the market with heightened warnings regarding its risks. GSK's stock price was lifted by the news, but the final impact on its bottom line has yet to be calculated. The FDA doesn't have to follow the advice, but chances are it will. That would mean ignoring the demand by its own safety expert, David Graham, that the drug should be yanked. But the agency hasn't had any trouble tuning out Graham in the past.
Avandia has been steadily losing market share since Dr. Steven Nissen at the Mayo Clinic released data from a meta analysis demonstrating heightened cardiovascular risks. A black box warning is likely to continue to crimp the market for the blockbuster diabetes drug. Analysts also noted, though, that Glaxo has been doing a good job gaining new drug approvals.
- see this release from GSK
- read the report from the International Herald Tribune
ALSO: The Wall Street Journal gathered some of the most pessimistic forecasts for Avandia. Report (sub. req.)