Orexigen Therapeutics Inc. (OREX:US) fell the most in three years after regulators pushed back a decision on whether to approve the company’s obesity drug NB32.
The company dropped 15 percent to $5.81 at the close in New York, the biggest single-day share decline since June 3, 2011. La Jolla, California-based Orexigen had gained 6.7 percent in the 12 months through yesterday.
The Food and Drug Administration extended its review to work out an agreement with Orexigen on post-marketing obligations related to evaluating the drug’s effect on the heart, the company said in a statement. The new decision date is Sept. 11. Osaka, Japan-based Takeda Pharmaceutical Co. (4502), Asia’s largest drugmaker, would market the weight-loss pill in the U.S.
“We are encouraged by the high level of engagement with the FDA, and are confident that we can reach agreement on the remaining post-marketing obligation,” Orexigen Chief Executive Officer Michael Narachi said in the statement.
Orexigen’s application for NB32 approval includes interim safety and cardiovascular outcomes data for a 8,900-patient clinical trial called the Light Study. The study is assessing patients who have a cardiovascular risk factor, such as heart disease or type 2 diabetes, according to Orexigen.
NB32 combines bupropion, also used in antidepressants, to help curb appetite and naltrexone, also used to combat alcoholism and opioid dependence, which Orexigen said increases drug tolerability.
The FDA approved two weight-loss pills in 2012, Belviq from Arena Pharmaceuticals Inc. (ARNA:US) and Eisai Co (4523) and Qsymia from Vivus Inc. (VVUS:US), that are being studied post-approval to determine their effect on the heart. Belviq, Qsymia and NB32 had been previously rejected on safety concerns.
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