FDA Delays Decision on Orexigen Obesity Pill by 3 Months
The FDA extended the review of
(OREX - Get Report) obesity pill Contrave by three months.
Wednesday's expected approval decision is now pushed back to Sept. 11.
"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 Report) and Arena Pharmaceuticals (ARNA - Get Report) lack data ruling out an increased risk of heart-related side effects.