My predictions for next week's two very important FDA advisory panels:
Vivus: Positive vote! Panel will recommend Qnexa's approval.
Chelsea Therapeutics (CHTP): Positive vote! Panel will recommend Northera's approval.Who says I'm always Mr. Negativity? For Vivus, I'm betting on the politics of obesity drugs outweighing the lingering safety concerns about Qnexa. The drug clearly helps fat people lose weight and FDA is under pressure to approve something for weight loss. Qnexa may be saddled with restrictions and safety warnings, but it's going to win this time around. Chelsea took a hit Monday when it "pre-announced" the FDA's questions (too short clinical trials, patient deaths) related to Northera as a treatment for hypotension, or dangerously low blood pressure, in patients upon standing. It's now up to Chelsea and its advisors to defend the drug and convince the panel to vote yes against what might be strenuous FDA opposition. This isn't an original observation, but others have likened Chelsea to Acorda Therapeutics (ACOR), which also overcame a tough and highly critical FDA review to win the backing of an advisory panel and ultimately, a full drug approval. I listened to Chelsea's CEO this week at the BIO CEO & Investor Conference, and I came away feeling like the company has a good argument to make favoring Northera's safety. The bigger question comes down to the endpoints and duration of the clinical trials used to assess the drug's clinical benefit. Chelsea and FDA reached an agreement in advance on these trial designs. While it's the agency's prerogative to change its mind, I don't think that will sit well with the experts on the panel given the serious nature of this disease. For that reason, I'm predicting a Chelsea win. One more Vivus note: As you read this column today (Friday), the FDA will have likely already released its second review of Qnexa. You'll be able to find the FDA's Qnexa briefing documents on the agency's Web site.
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