Early Heart Data Look Good for Obesity Drug
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Interim data from a cardiovascular safety study of an investigational weight-loss agent have met FDA criteria, and drugmaker Orexigen Therapeutics will seek to resubmit the drug for U.S. approval.
A company press release reported that the combination of naltrexone and bupropion (Contrave) didn’t double the risk of major adverse cardiovascular events (MACE) compared with placebo - a requirement set by the FDA - in an interim look at data from the Light Study, a cardiovascular outcomes trial.
The drug was denied FDA approval in February 2011, even though an advisory committee had voted largely in favor of approval. The agency required that the company conduct a cardiovascular outcome trial before it would approve the drug.
It also agreed that if the study could exclude a doubling of the risk of MACE with the drug compared with placebo, the company could submit the interim analysis for consideration in a resubmitted new drug application (NDA).
Orexigen said it plans to do so soon, with plans for U.S. approval of the drug by June 2014. It also submitted a Marketing Authorization Application to the European Medicines Agency in October 2013, with hopes for approval there by the second half of 2014.
The company also reported no new safety signals in the Light Study, which randomized about 8,900 patients from 260 clinical sites across the country.
Louis Aronne, MD, of Weill-Cornell Medical College in New York City, said the findings are “promising.”
“What one would really like to see is a reduction in cardiovascular risk,” Aronne told MedPage Today. “If risk of Contrave is increased but not to double the placebo risk, it could be approved—but it would not inspire confidence once on the market.”
He added that the diabetes drug liraglutide (Victoza) is also being investigated as a weight-loss agent and may hold promise as a treatment for obesity.
“We clearly need more medications for the treatment of obesity,” he said, “that’s for certain.”
Steven Smith, MD, president of the Obesity Society, said in a statement that Contrave, if approved, could be a useful part of the obesity treatment toolbox.
“Obesity medications provide an additional tool for obesity clinicians and produce the most weight loss when combined with diet and exercise,” Smith said, cautioning, however, that the drugs are “not for everyone, and they are not for short-term weight loss.”
“These obesity medications are no different from others approved by the FDA, requiring a thorough physician assessment of each individual patient and continued monitoring of health for success,” he said.
Smith noted that “given the complex nature of obesity, there is no magic bullet” and society needs to support research for more effective weight loss strategies and drugs: “Currently, there are more than 100 drugs for hypertension, yet only two approved for long-term use for obesity.”
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By Kristina Fiore, Staff Writer, MedPage Today
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