Biopharmaceutical firm Orexigen Therapeutics (OREX) has submitted the marketing authorisation application (MAA) to the European Medicines Agency (EMA) for its Contrave drug.
The company hopes to win approval for Contrave to manage obesity, including weight loss and maintenance of weight loss, in combination with lifestyle modification.
The company expects to make Contrave available to physicians and their patients in Europe in early 2015, subject to completion of the review process and potential approval in the second half of 2014.
Orexigen is currently assessing Contrave in the Light Study, a multicentre, randomised, double-blind, placebo-controlled long-term research study.
The primary objective of the cardiovascular outcomes trial, which has more than 8,900 patients randomised to Contrave or placebo, is to rule out excess cardiovascular risk in overweight and obese patients receiving Contrave.
Orexigen expects to follow up with a planned interim analysis of the Light Study by early December 2013 after at least 87 major adverse cardiovascular events have occurred in the trial.
In addition, the company also plans to resubmit the Contrave new drug application to the US Food and Drug Administration by year-end.
Orexigen CEO Michael Narachi said obesity is one of Europe's great health care challenges, with it tripling in many European countries in the past few decades.
"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," Narachi said.
Earlier this year, Orexigen received approval from the EMA rapporteurs to submit the Contrave MAA prior to the light study interim analysis and to make available cardiovascular outcomes data from the light study for the Committee for Medicinal Products for Human Use (CHMP) Day 120 List of Questions.
In addition, the company also received consent from the EMA for a pediatric investigation plan in children and adolescents.
While Orexigen has licensed North American commercial rights for Contrave to Takeda Pharmaceuticals, it has retained the rights in Europe and the rest of the world.
Contrave, an investigational medication being evaluated for weight loss, is a fixed-dose combination of bupropion sustained-release (SR) and Orexigen's proprietary SR version of naltrexone.
It is designed to improve drug tolerability and is believed to reduce appetite, help control cravings, increase metabolism and improve control over eating behaviours.
Image: Illustration of obesity and waist circumference. Photo: courtesy of Victovoi.