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Top FDA Approval Decision Gurus Weigh In on Vivus' Obesity Drug

Patrick Crutcher (Twitter @chasingthealpha)

Contest record to date: 10-3

Hometown: Los Angeles.

Age: 27

Occupation: Co-founder Chimera Research Group; Statistics PhD candidate at UCLA.

The secret to your FDA drug approval picking success: Keep digging until your brain is near fried, extra crispy preferred. I've been as successful as I have because I try to understand all aspects behind the drug's development from the scientific rationale to trial design. Everything with the FDA is about safety and efficacy, so you always need to put yourself in the shoes of the regulators. Additionally, it always pays to be skeptical of small-cap biotechs, especially when it comes to their statistical and manufacturing portions of their new drug applications. Too many companies try taking shortcuts that only make the path to approval longer.

Your Vivus Qnexa prediction: Approval. Why? That's the million-dollar question. Like I said, it's a balancing act between safety and efficacy in the indication. For example, the possibility of increased cardiovascular safety issues coupled with mediocre weight loss won't cut it in an indication like obesity. Without giving too much away, I think Vivus has made a great case for approval in terms of safety and efficacy, which is something neither Arena Pharmaceuticals nor Orexigen Therapeutics has done.

Bonus question: Will FDA approve Arena Pharmaceuticals' lorcaserin on June 27? No.

Paul Danese (Twitter @pdoofus)

Contest record to date: 10-3

Hometown: Glastonbury, Conn.

Age: 43

Occupation: Run a consulting business related to FDA drug safety.

The secret to your FDA drug approval picking success: Luck (lots of it) and maybe some experience. I've been investing in biotech stocks and following FDA for many years.

Your Vivus Qnexa prediction: Approval. Why? The Jan. 9, 2012 press release indicating that FDA asked Vivus to remove the childbearing-female contraindication from the proposed label was a pretty strong sign. The advisory panel vote (20-2) was strongly positive. Qnexa meets FDA's pre-specified efficacy thresholds for obesity meds. Qnexa's active ingredients are already approved.

Bonus question: Will FDA approve Arena Pharmaceuticals' lorcaserin on June 27? No.

Joseph Lee (Twitter: @fda_tracker)

Contest record to date: 10-3

Hometown: San Francisco

Age: 30

Occupation: Graduate student in Pharmaceutical Sciences and Pharmacogenomics. Founder of

The secret to your FDA drug approval picking success: There is no secret, just lots of hard work. Reading primary literature (peer-reviewed journal articles, conference abstracts, published posters). Reading company press releases, SEC filings, listening to conference calls. Learning from history (what is the current FDA guidance, how has the FDA ruled on similar drugs in the past, how do they view different classes of drugs.) Discussions through Twitter and offline to hear opposing viewpoints. Putting it all together in a logical argument for my thesis, as I do on my website. And of course, some luck.

Your Vivus Qnexa prediction: Rejection. Why? A March 6 article in Circulation states: "A targeted approach would first focus on the mechanism of action of the drug. If preclinical and early clinical evidence indicates a concern that the drug may increase cardiovascular risk (as would be the case for sibutramine, phentermine/topiramate, and the naltrexone/bupropion combinations), then exposure to the drug product would need to be sufficient to rule out specific cardiovascular safety concerns."

Phentermine (increases norepinephrine levels) and buproprion (norepinephrine re-uptake inhibitor) increase blood pressure through a similar mechanism of action. Hiatt, Thomas, and Goldfine (authors, EMDAC voting members) and Colman (reviewer, FDA division director) are making an explicit comparison between the cardiovascular safety of Contrave and Qnexa.

At the March 28 obesity EMDAC, the vote was 17-6 in favor of a two-tier cardiovascular safety study even in cases where there is no cardiovascular safety signal. Additionally, EMDAC reiterated their desire for strict MACE endpoint, which has been the criteria for all diabetes cardiovascular safety trials, including Contrave's.

Contrave's cardiovascular outcomes trial requires demonstrating the upper limit of the 95% confidence interval for the MACE hazard ratio less than 2. This is similar to the diabetes guidance, which states the upper limit less than 1.8. Qnexa does not satisfy either criteria, as the upper bound for the strict MACE confidence interval is 2.64.

Qnexa's phase III trials did not accrue enough cardiovascular events to statistically rule out cardiovascular risk based on strict MACE. Logically, if FDA follows the precedent it set with the diabetes drugs and Contrave, then a pre-approval cardiovascular outcomes trial for Qnexa would be required. Arguments for approval based on the component drugs already being approved or the drugs being used off-label do not apply since they did not apply to Contrave's similar situation.

FDA is different from EMDAC. It's possible there is political pressure to approve Qnexa or FDA will be more flexible given Qnexa's efficacy. I may be relying too much on a strict interpretation of the current guidance. I certainly could be wrong, but I do not believe approval is as assured as some have suggested.

--Written by Adam Feuerstein in Boston.

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Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.
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