Here is the detail SAN DIEGO, July 30, 2014 /PRNewswire/ -- Orexigen Therapeutics, Inc. (Nasdaq: OREX) today announced it has received the Day 180 List of Outstanding Issues (LOI) from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for the NB32 Marketing Authorization Application (MAA). NB32 (naltrexone sustained release (SR) / bupropion SR) is an investigational drug candidate being evaluated for weight loss.
The key questions of the earlier Day 120 time point were adequately addressed by the Company based in part on the interim analysis of the Light Study cardiovascular outcomes trial. However, the Day 180 LOI raised new issues. Specifically, the CHMP requested further justification of the balance of benefits and risks of NB32 treatment as well as additional information regarding post-approval risk minimization measures and pharmacovigilance activities. Details were also requested of the Company's third-party suppliers of bupropion related to their starting materials.
The Company believes the CHMP's requests are addressable. However, in regards to the third-party suppliers, in order to have the time to coordinate responses from these suppliers, Orexigen has requested an extension of one month and plans to submit its response to the Day 180 LOI in September.
"We believe NB32 has a benefit risk profile that supports approval, and we are confident in our ability to justify its profile to the CHMP," said Michael Narachi, CEO of Orexigen. Less
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