Vivus' ($VVUS) weight-loss drug Qsymia was approved last year in the U.S. by the FDA to great fanfare. Europe, where the shadow of a diet drug scandal lingers, has not been so inviting.
After being turned down by the European Committee for Medicinal Products for Human Use (CHMP) in October, Vivus asked that the drug, called Qsiva there, get a second look. Regulators' message today couldn't be more clear. They were not prepared to approve it last October. They are not ready to approve it now and they will not even consider approving it in the future unless the company does a new trial on its cardiac dangers.
The regulator for the European Medicines Agency (EMA) raised a red flag over the heart risks of Qsiva ingredient "phentermine, which is known to increase the heart rate but whose long-term effects are not clear." The EMA also noted there are concerns about "psychiatric effects," and risks to unborn children if taken by pregnant women. Topping it off, CHMP noted there is a good chance the drug would be used by people for whom it is not really intended.
That language harkens back to the Mediator scandal in France which is still playing out there in the courts. For 10 years after other countries had withdrawn the French diabetes drug from the market, authorities in France permitted drugmaker Servier to sell it there. It was often prescribed for weight loss. But the drug was tied to serious heart problems in thousands of patients and at least 500 deaths. When the matter reached the outrage factor in France, the country launched a probe into ties between the company and regulators and the top drug regulator resigned.
Vivus today said it was disappointed with the CHMP decision, but probably no more than investors who had expected a faster uptake of the drug. It and Arena Pharmaceuticals' ($ARNA) drug Belviq were the first diet pills in a decade to get through the FDA. Some analysts have been adamant that Vivus needs a partner with marketing muscle for it to reach its blockbuster potential. But some experts have suggested Vivus is more likely to get there by rolling it out in a slow and methodical way, getting buy-in from doctors and managing public perceptions carefully.
- read the EMA's insights (PDF)
- here's Vivus' statement