EMA committee shoots down Vivus diet pill

European regulators aren't sold on the new Vivus weight loss pill. The Committee for Medicinal Products for Human Use nixed Vivus' ($VVUS) application for approval, citing worries about Qsiva's safety and probable off-label use. The committee's rejection means Qsiva's European debut will be delayed for about 6 months--if not indefinitely.

Sold as Qsymia in the U.S., the Vivus drug launched recently, accompanied by a barrage of media coverage. Not only an important product for Vivus, Qsymia/Qsiva is seen as a promising aid to reversing the tide of obesity in the States. It's expected to earn blockbuster status, after a slow start as doctors gain experience using it--and its soon-to-launch rivals.

Vivus wasn't expecting a warm reception from European officials, and those expectations bore out. The committee said it was worried about Qsiva's long-term effects on the heart and blood vessels, particularly because Qsiva contains the active ingredient phentermine, once notorious for its use in the fen-phen diet-pill combo. Phentermine isn't approved in Europe, though it is in the U.S.

The drug's other active ingredient, topiramate, is a seizure remedy that's been on the market for years--and known to carry a risk of birth defects. Plus, the CHMP noted concerns about long-term psychiatric effects, because depression and anxiety cropped up in clinical trials, and long-term memory and attention problems.

Recent news for Qsymia in the U.S. has been mixed. Analysts reported earlier this month that payers were proving more willing to cover the drug than initially expected, with about one-third approving it for use so far. But doctors attending a recent conference suggested that they'd consider prescribing phentermine and topiramate individually rather than the branded drug, as a lower-cost way of treating patients with the combo.

Vivus says it plans to appeal the CHMP's decision. Cowen & Co. analyst Simos Simeonidis said new reviewers will look at Qsiva during its appeal, which may improve its chances. Regardless of the outcome--and regardless of the expected slow-but-steady build in prescriptions, Simeonidis figures that the demand for obesity drugs and Qsymia's early reputation for "robust weight loss" will fuel peak sales of $1.6 billion in the U.S. by 2019.

- see the report from the CHMP

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