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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