18-0! You can't get any better than that. There's little doubt that Merck's
Victory-elis is more like it.
There was only one voting question: Do the available data support approval of boceprevir? To which the panel of experts gave a resounding yes.
But there were actually five questions the agency posed to the committee, two of which could affect sales of the drug in a major way. The panel was asked, for instance, how to handle the treatment of specific subsets of patients, such as blacks or those who failed a previous treatment. The FDA will take the panel's input, which was somewhat negative, into account in determining the label that guides doctors' prescriptions.
If Victrelis was the only option to add to the current standard of care, the label wouldn't be that big of a deal. Victrelis or nothing? Doctors would pick Victrelis.
But Victrelis will go up against Vertex Pharmaceuticals'
It doesn't look like we'll have to wait too long to see the label. Merck said its PDUFA date is in mid-May. And the chance of anything less than an approval looks fairly slim.
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