The cost of developing an obesity drug looks like it's going up substantially. You can blame it on fen-phen and Abbott Labs'
Yesterday a Food and Drug Administration advisory panel voted 17 to 6 recommending that obesity drugs that don't have a signal suggesting that they cause detrimental heart problems should still be required to have large clinical trials run to determine their cardiovascular risk.
The FDA doesn't have to go along with its advisors, but I think it's a foregone conclusion that the agency will follow the advice of the outside experts on this one. The agency would look like idiots if they went against the panel's advice as soon as some drug is discovered to cause heart problems post-approval.
The only saving grace for drugmakers is that most panelists seem to believe it will be sufficient to carry out the studies after the drug is approved. At least companies will have revenue coming in while they wait to see if their drugs can stay on the market.
That's especially good news for VIVUS
Orexigen's
Diabetes drugs already have a requirement to show that they're not increasing cardiovascular risk -- their fall guy is GlaxoSmithKline's
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