VIVUS, Inc. (NASDAQ:VVUS) wants to make the anti-obesity medicine more widely procurable for customers

VIVUS, Inc.(NASDAQ:VVUS) has called for a reconsideration of, and an amendment of the Risk Evaluation and Mitigation Strategy requirement. The FDA had asked the company to get REMS for their new anti-obesity drug, which the pharmaceutical now wants to be looked into, again. Qsymia, which is the drug, is not widely available at present due to the Risk Evaluation and Mitigation Strategy. But if the FDA does look into it, and agree to the reconsideration, then the drug can be made more widely available to many more consumers.

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The FDA had approved the drug, but they had put the REMS clause in place. This was done in July, this year. Under the strategy, the prescription for the anti-obesity drug would have to be mail order pharmacies which were qualified enough. Training from healthcare provider, Medication guide, educational tools ad well as patient brochure were the other specifications which the FDA placed. Vivus had made a deal with the pharmacy chain of Express Scripts with regards to the prescriptions clause. REMS requirements may not be very stringent, but they do restrict the widespread availability of the drug. Vivus, keeping in mind the greater distribution of the medicine, has called for the reevaluation. After it got approved by the FDA with the clause in July, the medicine was launched to the public in September, around the middle of the month.

The company may have been selling Qsymia only for about a month now, but they have already managed to get themselves a distribution deal, and they want their medicine to be more widely available, to increase sales and popularity, hence the bold demand from the FDA. Vivus, however, has not been there on the news for all the good reasons. The company’s negligence to get approval from Europe has been talked about, a fair amount. The market is also waiting to get proof of the results of Qsymia. If the drug manages to sell well enough, then Vivus equity might grow quite a lot. About ten percent of growth is the average anticipated rate. 

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VIVUS, Inc. (NASDAQ:VVUS) shares Extend Friday’s Fall, Down 15% In 2 Session - Arena Pharmaceuticals (ARNA)

Shares of VIVUS, Inc.(NASDAQ:VVUS) dropped another 9% at $19.07 after falling 5% in Friday’s session, after it announced that its obesity drug, the first diet pill released in US in more than 10 years, might not be approved by a European regulatory committee. There have been safety issues with obesity drugs before like the infamous "fen-phen" diet-drug combo, which is why regulatory committees have become more stringent.

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Cowen and Co analyst Simos Simeonidis states that an approval in the future by the European Union is unlikely due to the numerous issues that have been raised by them, such as the lack of comfort with phentermine in Europe. Vivus's Qsiva has phentermine, which suppresses the appetite, along with the anti-seizure drug topiramate. An obesity pill was released in Europecalled Acomplia, but was taken off the market due to enhanced suicide risks.

The final decision about Qsiva from the European Medicines Agency's Committee for Medicinal Products for Human Use will be pending till October. If the results are negative, Vivus will re-evaluate their marketing application later and submit it again or opt for a review via an appeal. Simeonidis said that Vivus will be able to eliminate a part of the acquisition premium assigned by some investors.

The U.S. Food and Drug Administration in July had given the green signal to Vivus’s drug with the name Qsymia. Arena Pharmaceuticals’s Belviq was also approved by them and it is the first diet pill to be given the go-ahead in 13 years. Belviq is likely to be released next year, whereas Vivus has unveiled their product in September. 

Shares of Arena Pharmaceuticals, Inc.(NASDAQ:ARNA) are down 4.50%.

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