- Bloomberg, Wednesday, December 8, 2010 10:25 AM
The La Jolla, Calif.-based company watched the Food and Drug Administration's focus on safety and learned that a commitment to minimize Contrave's risks and additional studies would be necessary to
support approval for the drug.
Outside advisers to the FDA had recommended that a large study on cardiovascular risk can wait until after Orexigen Therapeutics' drug is approved. The FDA
delayed competing treatments from Arena Pharmaceuticals and Vivus in October after they failed to win the panel's backing on safety.
While the FDA isn't obliged to follow the recommendations
of its advisers, their support eases concerns that had caused Orexigen shares to drop by more than a third this year.
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