Orexigen Therapeutics, Inc. (Nasdaq: OREX) and Takeda Pharmaceutical Company Limited (Takeda) (TSE:4502) announced today 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® (naltrexone sustained release (SR)/bupropion SR) 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.
"We are encouraged by the panel's view of the risk-benefit profile of Contrave," said Michael Narachi, president and CEO of Orexigen. "We look forward to continued discussions with the FDA regarding the design of a post-marketing study to evaluate cardiovascular risk and to address the questions raised at the meeting today in preparation for our PDUFA action date in January."
The advisory committee\'s decision is a non-binding recommendation to be considered by the FDA in finalizing the review of the Contrave New Drug Application (NDA). A PDUFA action date of January 31, 2011 has been assigned for the review of the NDA.
"We are pleased with today's committee vote, an important step on the path to approval for this potential new option for the treatment of obesity and an example of the dedication of the Orexigen-Takeda team," said Shinji Honda, president and CEO of Takeda Pharmaceuticals North America, Inc., a wholly-owned subsidiary of Takeda. "Takeda is committed to working to provide new treatment options in managing obesity and helping physicians address this growing epidemic. We believe Contrave, if approved, could be an important addition to the limited therapeutic options currently available."
Orexigen management will host a call and webcast to discuss this update tomorrow, December 8, 2010 , at 4:15 p.m. Eastern time. The live call may be accessed by phone by calling (866) 510-0712 (domestic) or (617) 597-5380 (international), participant code 63015455. The webcast can be accessed live on the investor relations section of the Orexigen web site at CONTACT: Investor relations, Graham Cooper, Chief Financial Officer of Orexigen Therapeutics, Inc., + 1-858-875-8600 ; or Media, Liz Frank, + 1-212-301-7216 , or Carolyn Wang, + 1-415-225-5050 , both of WCG for Orexigen Therapeutics, Inc.; or Seizo Masuda of Takeda Pharmaceutical Company Limited, 81-3-3 278-2037 ; or Jocelyn Gerst of Takeda Pharmaceuticals North America, Inc., + 1-224-554-5542