This week, the FDA continued with its own version of March Madness, scheduling advisory panel hearings on numerous drugs and medical devices. GlaxoSmithKline's
Relenza is primarily used to reduce flu symptoms. It is best known for being one of the two drugs (the other was Gilead Sciences'
In a vote yesterday, an FDA advisory panel suggested that the Relenza label should be strengthened to include the possibility of abnormal behavior and hallucinations in those who take it.
Glaxo has had an interesting experience with Relenza at advisory panel hearings since its approval in 1999. Glaxo first filed a marketing application with the FDA for the drug after completing three late-stage clinical trials. Prior to its approval, an advisory committee meeting was held to discuss the drug's safety and efficacy. After an FDA reviewer recommended against the drug's approval, 13 out of 17 panel members voted that the drug failed to show efficacy and shouldn't be approved.
Advisory panel recommendations, however, are not binding on the FDA's decisions to approve or deny a drug. In a case opposite to what happened with Dendreon
Sales of Relenza were $168 million last year and $372 million in the first nine months of 2007, thanks to growth from governments stockpiling the drug. With overall pharmaceutical sales of $37 billion last year, the added safety concerns to the Relenza label will have a modest impact (if any) on Glaxo's top line. Still, Relenza's history shows the unpredictability of the FDA, and what can happen when investors put too much stock in the outcome of an FDA advisory panel hearing.
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