6/26/2012 7:11:59 AM
There are conflicting messages coming out of recent FDA advisory panels. On March 29, 2012, an Endocrinologic and Metabolic Drugs Advisory Committee voted to require cardiovascular outcome trials (CVOT) using major cardiovascular events (MACE) as the primary endpoint. But on May 10, 2012, another Endocrinologic and Metabolic Drugs Advisory voted 18-4-1 in favor of approval of Arena's (ARNA) obesity drug, Lorcaserin (briefing document for that meeting). The dynamics of the panelists views on the first committee addressing cardiovascular safety of obesity drugs (March 29, 2012) are interesting. The vote was 17-6 in favor of requiring CVOTs for obesity drug approval.
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