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The Wall Street Journal, U.S. Edition
Monday, November 25, 2013 As of 8:21 AM EST
Orexigen to Resubmit FDA Application for Weight Loss Drug
By Everdeen Mason
Biopharmaceutical company Orexigen Therapeutics Inc. (OREX) said it will resubmit its new drug application for its weight loss drug in the next few weeks after ruling out cardiovascular risk in obese and overweight patients in a study. The company has been developing a weight-loss ingestible pill called Contrave that it now hopes to be approved by the U.S. Food and Drug Administration by June 2014.
Orexigen had said in January that the FDA had agreed to a data evaluation process that should allow the company to seek approval of its drug later this year and receive a decision by early 2014.
As America’s growing waistline has become a public-health issue, a handful of pharmaceutical firms, including Orexigen, Vivus Inc. (VVUS) and Arena Pharmaceuticals Inc. (ARNA) have raced to capitalize with new medications. All three have faced major hurdles, though both competitors’ drugs are already on the market. In the study, Orexigen has sought to prove Contrave doesn’t pose cardiovascular risk to overweight and obese patients in order to receive agency approval. It conducted a controlled study that randomized about 8,900 patients.
The company is confident the study’s data “will support a favorable benefit/risk assessment for Contrave,” Chief Executive Michael Narachi said. The company also said Contrave showed a 95% confidence interval that it won’t cause major cardiovascular events and no other safety issues in the study. Orexigen partners with Takeda Pharmaceuticals Co. (TKPYY) on Contrave in North America.
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