Vivus' Formal Rejection in Europe: A Win for Arena & a Wake-Up Call for the FDA

REZA is a member of The Motley Fool Blog Network -- entries represent the personal opinion of the blogger and are not formally edited.

Last month Vivus (NASDAQ: VVUS) informed investors that the company's weight loss drug, Qsymia (Qsiva) would get rejected by the European Medicines Agency committee. Yesterday, the Committee for Medicinal Products for Human Use (CHMP) issued a formal recommendation against approval of the Marketing Authorization Application (MAA) of Qsymia (Qsiva) in the European Union.

Several American doctors were hoping that Qsymia would also get rejected in the US, but earlier this year the FDA approved Qsymia and to the surprise of many, the REMS program put in place was much more lenient than many had hoped for. Before Qsymia's approval many wrote to FDA warning it of dangers of Qsymia, but these calls fell on deaf ears.

At the same time, there may have been lobbying by powerful hedge funds and political powers who back Vivus, possibly the same group who were lobbying against Arena Pharmaceuticals' (NASDAQ: ARNA) Belviq (and who all turned out to be wrong when the FDA decided to side with science and not Wall Street's fiction, and approved Belviq). A large number of people, including doctors and patients, demanded FDA's approval of Belviq.

After approval of Qsymia in the US, some American doctors were appalled by what they viewed as an irresponsible decision by the FDA. One of the key risks of Qsymia is birth defects. Dr. Daniel P. Lopez, M.D., F.A.C.O.G., an obstetrician and gynecologic surgeon in Los Angeles, in a recent posting blasted the FDA for their approval of Qsymia. Dr. Lopez cited a survey reported on WebMD.

Dr. Lopez wrote: "A survey reported on WebMD "2 in 5 Women Don't Use Birth Control: Many Women Mistakenly Believe They Can't Get Pregnant" reveals that many women don't use contraception and the ones that do don't use it properly:

- 43% of women who had been pregnant had one or more accidental or unintended pregnancy
- About 50% of these women report that at least one of these pregnancies may have been caused by birth control failure, such as a broken condom.
- One in 10 women on birth control reported a perceived failure in the past year.

This makes the lack of FDA compulsory pregnancy testing in the Qsymia REMS even more disconcerting. Despite the physicians asking the patients to use birth control while on Qsymia they will still have a high percentage of patients who will get pregnant while on the drug. Shame on you FDA."

Europe saw through the hype and rejected Qsymia. In a press release, Vivus indicated the reasons as:

"due to concerns over the potential cardiovascular and central nervous system effects associated with long-term use, teratogenic potential and use by patients for whom Qsiva is not indicated."

Europe's strong wording against what some social media participants have called a “toxic cocktail” -- phentermine/topiramate combo drug Qsymia -- should be a wake up call for the FDA to at least reject Vivus' recent request to make an already too lenient REMS program even easier.

No matter how many analysts, journalists, hedge funds and politicians back Qsymia, doctors ultimately write the prescriptions and every doctor I’ve talked to prefers Arena’s Belviq over Qsymia because of Belviq’s excellent safety profile. Belviq does not pose cardiovascular risks by raising the heart rate, and it does not cause birth defects.

Belviq will get approved in Europe because it is safe and it meets Europe's efficacy requirements. Another indication of Belviq's superior safety over Qsymia is the fact that EMA rejected Vivus' pediatric investigation application for Qsymia, but it approved Arena's pediatric investigation application for Belviq.

One of the most positive signs for Arena as an investor, in my opinion, is that the CEO and founder of Arena, Jack Lief, has not sold a single share since founding the company. Have a look at Vivus management's heavy insider sales!


The views expressed above are only opinions and are NOT investment advice and are NOT medical advice. Please always do your own research. I am long ARNA and have no positions in the other stocks mentioned above. To find out more about my interests please visit www.rezamusic.com . If you like to join my private Arena-related mailing list send an email to (info -- at -- rezamusic -- dot -- com).

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