"The FDA has indicated that the review extension is needed to reach agreement on the post-marketing obligation related to the previously agreed upon evaluation of cardiovascular (CV) outcomes for NB32," Orexigen said, in a statement. NB32 is Contrave.
While the approval decision delay is a disappointment, it may work in Orexigen's favor if FDA allows cardiovascular outcomes data favorable to Contrave to be included in the weight loss drug's label. Orexigen's competitors Vivus (VVUS) - Get VIVUS, Inc. Report and Arena Pharmaceuticals (ARNA) - Get Arena Pharmaceuticals, Inc. Report lack data ruling out an increased risk of heart-related side effects.
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