Orexigen: Predicting Tuesday's FDA Panel
Update: Due to a transcription error, some of the vote counts from previous weight-loss FDA advisory panels were wrongly described in the original version of this column. Those vote counts have now been corrected.
LA JOLLA, Calif. (
) -- One way to predict the outcome of Tuesday's FDA advisory panel meeting for
Orexigen Therapeutics'
(OREX)
weight-loss drug Contrave is to look at how the experts sitting in judgment voted for the other weight-loss drugs from
Vivus
(VVUS) - Get Report
and
Arena Pharmaceuticals
(ARNA) - Get Report
.
Granted, past performance is not perfect predictor of future results, but it doesn't hurt to know how tough (or easy) these experts were in previous advisory panel meetings.
Lucky for you, I went back and did the research. What I found should both encourage and worry Orexigen Therapeutics as it gears up for Tuesday's all-important FDA advisory panel meeting.
Let's start with the positive stuff first: Of the 20 experts invited by FDA to review Orexigen's Contrave, 10, or half, also participated in the July panel that reviewed Vivus weight-loss drug Qnexa.
Five of these 10 experts voted to recommend approval of Vivus' Qnexa, with five voting against approval.
This might bode well for Contrave since it, like Vivus' Qnexa, is a combination of existing, approved drugs. At the very least, Orexigen knows that it has some panel members who are amenable to approving a new weight-loss drug because they voted previously in favor of Vivus' Qnexa.
The not-so-encouraging news for Orexigen: Ten of 20 Contrave panel experts also reviewed Arena's lorcaserin in September. Seven of these experts voted against lorcaserin, while three voted in favor.
Lorcaserin was voted down because the drug's marginal ability to induce weight loss was overwhelmed by the drug's safety risks. Contrave's efficacy isn't much better than what's seen with lorcaserin, while the drug also has concerning safety questions, mainly around blood pressure and heart rate elevations.
Contrave's cardiovascular risk profile somewhat resembles Abbott Lab's Meridia, which was recently pulled off the market after a September advisory panel meeting. Eight of the 10 experts who will be reviewing Contrave Tuesday voted to recommend Meridia's withdrawal from the market due to the drug's cardiovascular risks. These eight experts are the people Orexigen needs to be most worried about Tuesday.
The total wildcard for Tuesday: Six of the panel experts reviewing Contrave are entirely new to this process, meaning they didn't sit on either the Arena or Vivus panels. What they think about all these weight-loss drugs is unknown.
I have one more micro-analysis to throw out which may or may note bode well for Orexigen: Five of the 20 experts on Tuesday's Contrave panel participated in both the Vivus and Arena panels. With all that time spent reviewing obesity drugs, you could call these five the "super experts."
How did they vote? Two of the five -- patient representative Melanie Coffin and Harvard diabetes expert Dr. Allison Goldfine -- voted to recommend approval of both Vivus' Qnexa and Arena's lorcaserin. Another of the "super experts" -- cardiologist Dr. Sanjay Kaul -- also voted for Qnexa.
The two remaining "super experts" -- endocrinologist Dr. Abraham Thomas and endocrinologist Dr. Lamont Weide -- voted no, or against approval, for both Vivus' Qnexa and Arena's lorcaserin.
Does the slim majority of the "super experts" who voted in favor of Qnexa bode well for Orexigen's Contrave?
We'll know on Tuesday afternoon.
--Written by Adam Feuerstein in Boston.
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