At first glance, the documents don’t contain any big surprises in terms of safety or efficacy. And Orexigen’s had time to learn from what happened at the Lorqess and Qnexa panel meetings.
That said, Adam Feuerstein makes an interesting comparison- to Meridia, Abbott Labs’ diet pill that was pulled from the market this fall because of its cardiovascular risks. We’ve known that Contrave can raise blood pressure, but the memory of Meridia may influence some of FDA’s outside experts.
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.
An analyst at Rodman & Renshaw in New York had similar concerns in an interview with Bloomberg.
“They may have to do a thorough cardiovascular study before approval,” said Elemer Piros, an analyst at Rodman & Renshaw in New York, in a telephone interview today. “The clear precedent is Meridia. It’s so fresh in our minds that I don’t think the FDA wants to embark on a public experiment in an uncontrolled setting without this information.”
So if more studies will be needed, it’s a good sign that Leerink Swann analysts Joshua Schimmer and Steve Yoo are impressed with Orexigen’s long-term safety strategy, according to a note sent to investors.
While no FDA panel is without risk and the track record of obesity drugs at the Endocrine Division is unquestionably poor, we have been impressed with OREX’s strategic approach to tackling Contrave’s safety-issues head on and its rational explanation for a post-approval study commitment.
That’s important because at least some of what sank Vivus’s Qnexa at its FDA advisory panel evaluation was a desire for more long-term data.
But at the end of the day, panelists who voted ‘no’ felt like more long-term safety data was in order. From Feuerstein’s liveblog:
one of the “no” votes says obesity is a chronic disease, so tell me what happens to patients as they stay on the medication for years.
Like Qnexa, Contrave is a combination of two drugs that are already FDA-approved. But it remains to be seen whether Orexigen has learned enough from Vivus’s experience to put together a convincing case for the FDA panel.
Options abound for following Tuesday’s meeting. Lisa LaMotta, now at Elsevier Business Intelligence, will be covering the panel live. Follow her @BioWriterChik. Feuerstein will as well, @adamfeuerstein. And FDA will webcast the panel here.
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