EU Approval? Fat Chance!

In general, there's a little lower threshold for getting a drug approved by the European Medicines Agency than there is for approval by the Food and Drug Administration. Merck's (NYSE: MRK  ) Cordaptive, Cell Therapeutics' (Nasdaq: CTIC  ) Pixuvri, and InterMune's (Nasdaq: ITMN  ) Esbriet were all approved in Europe, but were -- at least initially -- rejected in the U.S.

But gaining FDA approval isn't a guarantee that its EU counterparts will follow suit. There are certainly some examples of the EMA finding something that it wasn't comfortable with that the FDA signed off on. It looks like we'll be able to add VIVUS' (Nasdaq: VVUS  ) Qsymia to that list. Or rather Qsiva, the name the biotech plans to use if it can ever get the drug approved in the EU.

VIVUS announced Friday that, after discussions with the EMA's Committee for Medicinal Products for Human Use, it believes the committee will give the drug a negative recommendation. As a reminder, the CHMP is essentially equivalent to the FDA, with the EMA just giving a rubber stamp, so its decision is fundamentally the final one.

Once the rejection is handed down next month, VIVUS could appeal the decision or it could resubmit a new application later if it thinks more data will help it gain approval.

The rejection probably shouldn't come as much of a surprise. VIVUS got around the FDA's concern that Qsymia increases the risk of birth defects if pregnant women take the drug by setting up a risk evaluation and mitigation system to track doctors prescribing the drug and offering it only through mail-order pharmacies. The EU doesn't have an equivalent system, which is the main reason that GlaxoSmithKline's Avandia was pulled from the market there, but the FDA allowed Glaxo to continue selling it stateside with severe restrictions.

Figuring out how this will affect other obesity drugmakers is difficult. If the issue is specific to Qsymia/Qsiva, it's likely good news for Arena Pharmaceuticals' (Nasdaq: ARNA  ) Belviq since it won't have competition in Europe if it can get approved. If it's more of a worry about obesity drugs in general, then it's clearly bad news. We'll have to wait and see the ruling to know which one for sure.

That isn't stopping Arena's investors from speculating which one it will be. They seem to be seeing this as moderately bullish news -- shares were up about 4% on Friday -- which I think is reasonable given that Belviq's safety profile is much cleaner than Qsymia's.

Want more details behind the Belviq vs. Qsymia battle? Check out The Motley Fool's new premium report on Arena Pharmaceuticals. It outlines the key opportunities and risks facing the company -- plus what investors should be monitoring. Click here to receive your copy now!

Fool contributor Brian Orelli holds no position in any company mentioned. Click here to see his holdings and a short bio. The Motley Fool has a disclosure policy.
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Read/Post Comments (4) | Recommend This Article (9)

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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 September 21, 2012, at 3:49 PM, bhasa04 wrote:

    European Medicine Agency had already rejected pediatric investigation application submitted by VVUS for topirimate/phentermine combo:

    http://www.ema.europa.eu/docs/en_GB/document_library/PIP_dec...

    They did approve similar application for Lorcaserin's application submitted by ARNA in 2011

    http://www.ema.europa.eu/docs/en_GB/document_library/PIP_dec...

  • Report this Comment On September 23, 2012, at 11:25 PM, bhasa04 wrote:

    Here are powerful testimonials from two different patients that were part of the Belviq/Lorcaserin clinical trail. Both lost >18% of their body weight after one year on Lorcaserin/Belviq without any side effects.The ARNA shorts just don't know what they are up against.

    www.youtube.com/watch_popup?v=vih0pxY23lY&vq=large#t=221

    www.youtube.com/watch?v=ZtZyUjeSQ2g

  • Report this Comment On September 23, 2012, at 11:46 PM, Foreeverlong wrote:

    Sorry, I really don't get the point of your article. The impending rejection of Qsymia by the EMA has nothing to do with whether Belviq will be approved.

    Many of us predicted that Qsymia would not be approved for the simple fact that Topamax is perceived as a dangerous drug. In contrast, Belviq poses no such danger to the patient.

  • Report this Comment On September 24, 2012, at 7:20 AM, SamFreedom wrote:

    These ARNA related articles get worse and worse. There is no battle between Qysmia and Belviq other than the imaginary one that ppl like you invent to create the sensationalism that gets views.

    There is little comparison between the two on a meaningful level. In medical circles, Qysmia comes with excess baggage.

    Belviq is the golden child

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