Orexigen Soaring in Early Pre-Market on Positive Recommendation from FDA

"Orexigen Therapeutics (OREX) and Takeda Pharmaceutical Company Limited announced that the U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee voted 13 to 7 that the available data adequately demonstrate that the potential benefits of Contrave outweigh the potential risks when used long-term in a population of overweight and obese individuals and support approval.

The Committee also voted 11 to 8 that a dedicated study to examine the drug's effect on risk for major adverse cardiac events should be conducted as a post-approval requirement versus pre-approval. "

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