Up 40%! Is Approval a Done Deal?


I'll be absolutely shocked if Onyx Pharmaceuticals' (NAS: ONXX) carfilzomib doesn't get approved next month. The multiple myeloma drug, which will go by Kyprolis when it's approved, received an 11-0 recommendation for approval, with one abstention, from the Food and Drug Administration advisory committee yesterday.

But that's not why I think it'll be approved.

It's the agency, and not the panel of outside experts, that has the final say in whether a drug is approved. Listening to the meeting yesterday, it was pretty clear that the FDA was fairly fond of the data. More than once, the agency seemed to come to Onyx's rescue when the committee members asked questions during the meeting.

That's in stark contrast to the briefing documents, which seemed considerably more critical of carfilzomib.

In retrospect, there was one clue that the FDA might be more positive than the briefing documents made it appear. As I pointed out in my preview of the meeting, there were no discussion questions before the voting question. The FDA usually has preplanned questions about lingering issues it has about the drug before the voting question on whether to approve the drug. For example, here's a breakdown of the questions at the last few drug advisory committee meetings.



Non-voting questions

Voting questions










Pfizer (NYS: PFE)




Johnson & Johnson (NYS: JNJ)




Gilead Sciences (NAS: GILD)




Arena Pharmaceuticals (NAS: ARNA)



Source: www.FDA.gov.

At the time, I figured the lack of discussion questions might make it tougher on Onyx, with no chance for the drug's supporters on the panel to pull those on the fence onto their side. Instead, it looks like it was a sign that the FDA had nothing interesting to specifically ask the panel about.

I'd be careful extrapolating from Onyx's win the next time there's only a voting question. I don't think we have enough data points; this is the only example I can remember when there weren't any additional questions. And just because the FDA doesn't have any specific questions, doesn't necessarily mean that the reviewers haven't figured it all out, and convinced themselves that the drug isn't worth approving.

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The article Up 40%! Is Approval a Done Deal? originally appeared on Fool.com.

Fool contributorBrian Orelliholds no position in any company mentioned.Click hereto see his holdings and a short bio. The Motley Fool owns shares of Johnson & Johnson.Motley Fool newsletter serviceshave recommended buying shares of Pfizer, Gilead Sciences, and Johnson & Johnson and recommended creating a diagonal call position in Johnson & Johnson. The Motley Fool'sdisclosure policythinks there should be discussion questions before election votes.

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