Why the FDA Won't Approve Lorcaserin and Qnexa (Yet)

After months of speculation and a pair of Food and Drug Administration advisory panels, FDA decisions for Arena Pharmaceuticals' (Nasdaq: ARNA  ) lorcaserin and VIVUS' (Nasdaq: VVUS  ) Qnexa are finally upon us.

Arena's PDUFA date is Oct. 22, while VIVUS' date with destiny is six days later on the 28th. The Prescription Drug User Fee Act (PDUFA) sets the goal for the FDA to make a decision by then, but the FDA is free to make a decision at any point before or after that date. A decision on lorcaserin especially could be delayed since the FDA advisory panel met just last month.

What's the chance of lorcaerin and Qnexa gaining FDA approval? I'd put it somewhere between unlikely and nonexistent.

Give me more
The FDA advisory panels tell the whole story. The panel voted 10-6 against recommending Qnexa, and 9-5 against recommending lorcaserin. In both cases, the panels wanted more safety data before recommending approval of the drugs. Fortunately, both companies already have trials in process that could potentially produce such data.

In Qnexa's case, there's two-year safety data from an extension trial. The generally positive data was released after the advisory panel, but it most likely won't be considered for this FDA decision. For lorcaserin, there's a trial in diabetics, although it's not clear if it's large enough to really answer the questions the panel of experts has.

Blame it on the ancestors
The agency isn't bound to follow its advisory panel's recommendation -- there are plenty of examples of when it hasn't -- but for the obesity drugs, that avenue is all clogged up by the remnants of previous obesity drugs.

The most famous is Wyeth's fen-phen. The drug was pulled from the market because of potential heart problems. Abbott Labs' (NYSE: ABT  ) Meridia was recently pulled from the market after a post-approval study revealed potential heart problems as well.

sanofi-aventis' (NYSE: SNY  ) Acomplia was never given the thumbs-up stateside, but the drug was approved in Europe. The suicidal behaviors and depression that U.S. regulators were worried about turned out to be problematic enough to justify pulling Acomplia from the market in Europe.

Everyone -- patients, doctors, and investors (especially investors) -- would like a new drug to help shed the pounds. But with diet and exercise available as relatively safe option, the agency is likely to error on the side of caution.

If the advisory panel had voted in favor of the drugs, I could see a reason to be somewhat optimistic, but the agency isn't going to go against its panel of experts. Imagine the outcries if the FDA approved the drugs against the advisory panels' recommendations, and then safety issues cropped up after they were on the market for a while.

Another red flag?
I'm not sure we need one, but here's some more bad news for investors hoping to sneak in an approval: A study of FDA decisions a few years ago revealed that applications submitted in the fourth quarter had the lowest approval rate by far. It could be that companies rushing to submit applications before self-imposed end-of-the-year deadlines tend to turn in sloppier work. It's also possible that the rush just makes the agency busy enough that it errs on the side of caution.

Not every drug expecting an FDA decision this month fits the first category. Amylin Pharmaceuticals (Nasdaq: AMLN  ) and Eli Lilly's (NYSE: LLY  ) Bydureon was submitted in April, but since it's a response to a previous rejection by the FDA, the agency gives itself six months to review the decision.

The third contender
What will rejections of Qnexa and lorcaserin mean for the third obesity drug that's currently under review? It's hard to say. Orexigen Therapeutics' (Nasdaq: OREX  ) Contrave has side effect issues of its own, but Orexigen will have the advantage of seeing how the other advisory panels and FDA rejections go before Contrave goes in front of the FDA advisory panel on Dec. 7.

Orexigen could learn enough from the first two to craft its presentation in such a way to get positive recommendation, but I'm inclined to think the FDA and its advisors are predisposed to reject any obesity drug on the first try. By requiring more data before approval, the FDA can somewhat cover their butts in case safety issues do crop up.

What do you think? Is the FDA willing to go against its advisors? Take the poll below and then fill in the details in the comment box below.

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Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. The Fool has a disclosure policy.


Read/Post Comments (7) | Recommend This Article (9)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

  • Report this Comment On October 19, 2010, at 3:40 PM, ArnaAnalysis wrote:

    You know "this analysis" is BS. You need to stop all your BS comments on here. All the news are not true...It never been true since ARNA was 7-8 BUCKS. Why would we believe your comments here? Who are you?

  • Report this Comment On October 19, 2010, at 3:42 PM, ArnaAnalysis wrote:

    Leave the company "ARNA" alone. Let the company does it things and make it better so FDA will approve the drug. The world will become a better place for many people. Get out of here, man.

  • Report this Comment On October 19, 2010, at 4:34 PM, WCoastGuynCA wrote:

    Why would you state that it's unlikely that the FDA would consider the positive two year safety data on Qnexa when Vivus' management has stated that they have presented the data to the FDA and it is being reviewed.

    If you review the minutes from the advisory panel's discussion of Qnexa it is obvious that if the panel had the two year safety data available to them at the time of the meeting that the vote may have been reversed in favor of approval.

    Personally I expect approval with restrictive labeling which would not allow prescribing the drug to women who may become pregnant.

    With 72.3% of males in the United States over the age of 20 either obese or overweight and 17% of all medical costs in the United States directly attributable to obesity I think it is time that the FDA used a little common sense and approved Qnexa.

  • Report this Comment On October 19, 2010, at 4:49 PM, KN96 wrote:

    Hey Brian: Do you understand the science behind this company's drug? Or do you know what happened during the FDA Advisory panel meet? If you have the balls (no offence) why don't you write an article on the FDA panels and the committee members like Eric Colman because it was he who screwed this company. We all should demand a formal and a detailed investigation on all FDA Panel members to expose the corruption.

  • Report this Comment On October 19, 2010, at 9:45 PM, xetn wrote:

    What we really need is to abolish the FDA. A much better solution would be private labs doing the due diligence on drug safety and efficacy.

    We are all familiar with UL's history of independent reporting on the safety of all types of products. It seems rather obvious that the same independent type lab could be set up and provide much needed non-political analysis on drugs.

    I believe it is a fallacy to believe the government can do anything efficiently or cheaply.

  • Report this Comment On October 20, 2010, at 1:14 PM, dnblack wrote:

    Sorry I don't have an angry comment; I just wanted to mention that I think you are correct on both Qnexa and Lorcaserin.

    This is my unprofessional opinion.

  • Report this Comment On October 21, 2010, at 2:41 PM, BuggyFunBunny wrote:

    Yeah let the drug companies hire their own watchdogs. It'll work out just like the Banksters hiring their own credit agencies. Right Wingnuts!!!!

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