The Food and Drug Administration approval of Bristol-Myers Squibb's
Even the midday announcement didn't surprise me. While I'd just as soon the FDA make the announcement after the market closes -- no reason to give those that notice the news first the upper hand -- I'm getting used to the new mode of operation.
What was a little surprising was the label that the FDA gave Yervoy. The label tells doctors about the drug and what the FDA has -- and by omission, hasn't -- signed off on. While doctors are free to prescribe a drug for anything they want, companies are only allowed to market the drug for the indications on the label.
Typically, labels are determined by the clinical trials that are used to support the marketing application; the population the drug was tested in is what the FDA will approve the drug for.
Yervoy was tested in patients that had failed other treatments, but the FDA approved the drug for patients earlier in their disease progression. Bristol-Myers recently announced that a trial testing Yervoy in the earlier population succeeded, so it would likely have been approved for the earlier indication eventually. But the approval allows Bristol-Myers to promote it to a broader population earlier than expected.
Bristol-Myers plans to charge $120,000 for the four-course regimen. That's even more than Dendreon
Of course, it's only good news if the companies can get payers to reimburse for the drug. While most of Yervoy's surprises have been revealed, there's still one more $0.12 million question.
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