When the EMA Says No, Try, Try, and Try Again

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Give VIVUS an A+ for effort.

The biotech is on its third attempt to get its obesity drug, Qsymia, approved in Europe. The European Medicines Agency's Committee for Medicinal Products for Human Use rejected Qsymia last year. VIVUS appealed the decision, but that was also turned down in February.

Last week, VIVUS said it asked the EMA for advice on using pre-specified interim analysis from its AQCLAIM cardiovascular outcomes trial to support the resubmission of its marketing authorization application.


AQCLAIM, which VIVUS plans to start in the first quarter of 2014, is part of its post-approval commitment to the FDA. It certainly makes sense to ask the EU for advice in designing the trial so VIVUS can double dip and use it to gain approval in the EU.

VIVUS didn't actually say when the interim data might be available to submit to the EMA, but we can take a guess based on Orexigen's clinical trial testing Contrave's cardiovascular safety, which began in June 2012  and is expected to produce interim results by the end of the year. Assuming VIVUS had approximately the same path, interim data might be available in 2015.

Is that all you've got?
While I'm sure the AQCLAIM trial will help EU regulators feel confident that Qsymia isn't causing cardiovascular problems, the issue was just one of many that they had with Qsymia. The first negative recommendation cited the potential for central nervous system effects associated with long-term use and birth defects in pregnant women.

For the most part, the EMA tends to be more stringent about safety issues than its U.S. counterpart because the EMA doesn't have the kind of post-approval regulation that the FDA has through its REMS program.

Quite frankly, if Arena Pharmaceuticals' Belviq, which has a much milder side effect profile, couldn't get past the EMA, it seems unlikely that the Qsymia will be able to without extensive additional studies.

Orexigen might have the best chance of approval in the EU since it'll have cardiovascular data in hand when the CHMP reviews Contrave. Assuming, of course, that the data show no increase in cardiovascular issues.

Investor confidence
Honestly, I think this announcement has more to do with regaining investor confidence than VIVUS actually being worried about a long-term potential to gain approval in the EU.

VIVUS has undergone two management changes this year. Investors can't have all that much confidence that the biotech can turn things around quickly.

Sometimes, looking like you've got a plan is half the battle.

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The article When the EMA Says No, Try, Try, and Try Again originally appeared on Fool.com.

Fool contributor Brian Orelli has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

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