Orexigen Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, has submitted the Marketing Authorization Application (MAA) for Contrave to the European Medicines Agency (EMA) utilizing the EMA's Centralized Procedure. Orexigen is seeking approval for Contrave (32 mg naltrexone sustained release (SR)/ 360 mg bupropion SR) for the management of obesity, including weight loss and maintenance of weight loss, in conjunction with lifestyle modification.
Assuming successful completion of the review process and potential approval in the second half of 2014, Orexigen would expect Contrave to be available to physicians and their patients in Europe in early 2015.
"Obesity is one of Europe's great health care challenges, with the prevalence of obesity tripling in many European countries in the past few decades," said Michael Narachi, CEO of Orexigen. "We believe, if approved, a medicine with Contrave's safety and efficacy profile, including safety information derived from the ongoing cardiovascular outcomes trial, can be an important part of the solution for the management of obesity in Europe."
Orexigen is currently evaluating Contrave in the Light Study, a cardiovascular outcomes trial with more than 8,900 patients randomized to Contrave or placebo. The primary objective of the double-blind, randomized, placebo-controlled Light Study is to rule out excess cardiovascular risk in overweight and obese patients receiving Contrave.
Earlier this year, Orexigen met with the European rapporteurs to discuss the filing strategy of the Contrave MAA, and both were supportive of the company's plan to submit the MAA in advance of the Light Study interim analysis and to have cardiovascular outcomes data from the Light Study available for the Committee for Medicinal Products for Human Use (CHMP) Day 120 List of Questions. The Company and the EMA have also agreed upon a pediatric investigation plan in children and adolescents.
By early December, Orexigen expects to conduct a planned interim analysis after at least 87 major adverse cardiovascular events have occurred in the Light Study. The company also plans to resubmit the Contrave New Drug Application to the United States Food and Drug Administration by year-end.
Orexigen owns Contrave rights in Europe and throughout the rest of the world outside of North America and will seek a partner to commercialize Contrave in those territories. Orexigen has licensed North American commercial rights to Takeda Pharmaceuticals.
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity.