FDA, EMA take yo-yo approach on diet pills

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Orexigen's experimental weight-loss drug Contrave may be making its way to the FDA earlier than expected. Like predecessors Qsymia (Vivus) and Belviq (Arena), Contrave's FDA consideration is a second go at passing muster, and its review had been idled while Orexigen's heart-safety studies get under way.

In the interim, however, the FDA has already approved drugs from competitors Vivus and Arena, and Orexigen is now asking the US regulator to consider reviewing its drug before it produces results from the Light Study, a cardiovascular outcomes study for which it is still enrolling patients. The company initially proposed the agency use existing data for its review, offering to provide data from the cardiovascular study at a later date, but the agency refused. This time, however, Orexigen is proposing to submit the data during the FDA review. Orexigen said in a statement that the FDA's response to the latest proposal “indicates that CDER highly supports further discussions regarding a faster path to resubmission.” CDER is the Center for Drug Evaluation and Research.

Less friendly was the European Medicines Agency's refusal to approve Vivus' weight-loss drug Qsvia, the overseas equivalent of Qsymia. The EMA said it rejected the request over concerns about the drug's possible cardiovascular impacts and the damage it could cause a fetus, should a patient become pregnant. The drug has been associated with memory loss, heart damage and birth defects, and patients are encouraged to take birth control while taking the drug.

The FDA approved the weight-loss medication in July, along with a REMS that limits distribution to select mail-order pharmacies. Vivus, meanwhile, filed a REMS modification request last week, and is seeking to make the drug available through select retail pharmacies. This would mean certain retailers could stock the drug like any other prescription. Senior Vice President and Chief Commercial Officer Mike Miller told MM&M the difference is that the selected retail channels could not then turn around and sell it to another pharmacy. The FDA has up to six months to review the application.

It is still early to gauge uptake, but Miller told MM&M that it has found in the three weeks since Qsymia has been on the market that payers are covering around one-third of the prescriptions. Miller attributed the change to a modified perception of just what the drug is tackling.

“I think the reasons for that is that both payers and employers have now come to the conclusion that obesity is a legitimate medical condition and is costing folks money,” he said, noting that conditions that are linked to obesity, such as high blood pressure and diabetes come with their own treatments. “I think that the realization of cardio-metabolic health and obesity has really sort of eclipsed the whole sort of cosmetic, diet pill thing,” he said.

The company has been marketing the drug though a staff of 150 reps, which is comprised of a mix of contracted sales force personnel as well as medical science liaisons. Miller said sales reps show up on calls with “iPads that have promotional materials on them that cover both obesity and its risk and the clinical study information for Qsymia.”

He said MSLs, who are an extension of the Vivus medical group, are deployed to “educate physicians and speakers” and typically come armed with a slide deck, training materials and reprints, and that he expects to expand the marketing push next year either organically or through a co-promotion with another sales force.

Qsymia prescriptions consist of two stages, and the REMS asks healthcare providers to prescribe two doses of the drug—14 days on a lower dose and 30 days on a higher dose—to new candidates. Miller explained that the 44 pills are covered within a month's span because the doses have distinct drug identifiers, which means they fit within the context of many plans monthly maximums for a given drug.

The full impact of the sales push is still building and the drug does have a seasonable angle to it that will most likely surface early next year. Miller noted that first-quarter drug sales are generally good as a whole, but “for whatever reason, obesity drugs also bounce up,” and acknowledged that it could have something to do with New Year's resolutions. Regardless, he said, Vivus is primed. “We do expect it.”
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