Orexigen has become the latest company to try and crack the obesity market in Europe, filing for approval of its investigational weight loss drug Contrave.
The US-based biopharma is looking to succeed where several companies have failed in recent years, due primarily to cardiovascular safety concerns.
In October 2012, Vivus faced a knockback from the European Medicines Agency (EMA) for obesity treatment Qsiva (phentermine/topiramate ER), despite receiving prior approval in the US.
Arena did not even get to hear a final EMA opinion, pulling its application for Belviq earlier this year after the regulator requested more data. Like its rival Qsiva, Belviq is also recommended in the US.
Orexigen is confident it can overcome the setbacks that held back these drugs in Europe, with the company expecting positive results from the Light Study to investigate the cardiovascular risk of Contrave.
The study involves more than 8,900 patients randomised to Contrave or placebo. Data will support the drug’s filing in Europe, which is expected to be complete in the second half of 2014.
If approved, Orexigen said Contrave should be available in the EU by early 2015.
“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,” said Michael Narachi, CEO of Orexigen.
Contrave combines the active ingredients bupropion and naltrexone. Bupropion increases the level of dopamine to reduce appetite, while naltrexone works by blocking opioid receptors to increase activity of POMC neurons, which is thought to lead to an increase in energy expended by the body.
Orexigen owns rights to the drug in Europe and the rest of the world outside North America. The company sold North American rights to the drug to Takeda. The drug is expected to be resubmitted to the US FDA by the end of 2013.
Other companies looking to enter the obesity market include Novo Nordisk, which is looking to expand the approved indications of diabetes treatment Victoza (liraglutide).