The Skinny on Upcoming Obesity FDA Meetings

Mark your calendars, biotech investors. Two obesity drugs are up for review by Food and Drug Administration advisory panels in the coming months.

Both VIVUS' (Nasdaq: VVUS  ) Qnexa and Arena Pharmaceuticals' (Nasdaq: ARNA  ) lorcaserin were turned down by the FDA in October 2010. But the companies addressed safety concerns and are headed back in front of advisory panels.

VIVUS will go in front of the firing squad on Feb. 22. Arena expects its meeting to be held in the second quarter.

It's a little unusual for the FDA to schedule an advisory panel to review a second attempt at approval. Usually the FDA feels confident that they can make a decision about whether the resubmission satisfied the requirements outlined in the first rejection.

For the average drug, I'd say scheduling an added advisory panel is bad news. As in the case of Cell Therapeutics' (Nasdaq: CTIC  ) pixantrone, it seems to be a sign that the FDA is looking for added confirmation that the drug shouldn't be approved. If the agency was convinced the companies had their ducks in a row, the FDA could just approve the drug on its own.

But I think obesity drugs are different because they've had so many problems with side effects popping up after approval -- Wyeth's fen-phen and Abbott Labs' (NYSE: ABT  ) Meridia -- that the agency might be looking for confirmation to go ahead with approval. This way, if the FDA approves the drugs and side effects become a problem once they're on the market, the agency can point to the advisory panel as evidence that they weren't the only ones that weren't cautious enough.

The results of the advisory panel are always important, but it seems the stakes might be just a little higher for these. A strong recommendation for approval might be all that the FDA needs to justify an approval to those worried about perception at the agency.

Going second might give Arena a slight advantage, but the issues for the two drugs are different enough that I don't think it really helps much. Both companies need to convince the advisory panel that theoretical side effects -- fetal oral clefts for Qnexa and cancer for lorcaserin -- aren't a problem. If they can do that, it should be possible to gain FDA approval.

But that's a big if.

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Fool contributor Brian Orelli holds no position in any company mentioned. Click here to see his holdings and a short bio. The Motley Fool owns shares of Abbott Laboratories. Motley Fool newsletter services have recommended buying shares of Abbott Laboratories. 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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  • Report this Comment On February 10, 2012, at 9:53 PM, PhillyDan wrote:

    Not a big if for Arena. There never was a cancer signal in the phase III studies and still not one despite what people who forgot how much cancer detection has improved.

    In addition, the WPG of 5, let me say that again 5 independent pathologists showed that the control groups in the 7x and 24x dosages had more malignant tumors vs. the drug group of female rats.

    Benign tumors of the type found in these rats does not progress to malignancy. Yes 82x the dosage had more malignant tumors in the drug group vs. control group but the safety margin is 24x, good enough for the 25x standard.

    For anyone saying it does not meet the standard well 24x to 82x is a long ways between the dosage level so whose say the safety margin is not 50x?

    The exposure margin for astrocytoma is estimated to be 70x based on the new studies. Yes, another person said well they didn't get it from the brain plasma and the CSF might not be good enough.

    That idiot wanted a study of drilling into human volunteers brains to collect plasma samples. For the record, the FDA agreed to the study design and protocol as they did for all of Arena's studies for the CRL issues.

    My guess is that at the advisory committee for Lorcaserin, that one of the expert presenters on behalf of Arena regarding the cancer issue will be Dr. Jose Russo, one of the leading experts on cancer in the World of the Fox Chase Cancer Center.

    Nothing is guaranteed, but I think Arena will be well prepared and had more than adequate results for the CRL issues.

    I do agree with Brian that the FDA wants an advisory panel to back up any decision both for Arena and Vivus.

    I think Vivus also has a good chance of gaining approval for Qnexa.

  • Report this Comment On February 11, 2012, at 12:24 PM, laker9029 wrote:

    Thanks Phillydan. .... a very good summary of the Arena situation. Arena has done a great job of addressing the CRL and if the AP is fair, and the FDA is objective and unbiased, Arena should get approved. Add the positive side effects of lowered A1C and potential as a first line treatment for diabetes, as well as the positive effects on BP and heart rate and those fighting obesity may finally have some help beyond diet and exercise.

    L

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