Europe Opens the Way for Two New Obesity Drugs
Let’s just say it. European regulators were spooked by obesity drugs for quite a few years. So news that first buproprion/naltrexone (Contrave U.S./Mysimba EU) and now liraglutide (Saxenda) have been recommended for approval in Europe is good news indeed.
What spooked the Europeans was the experience with rimonobant. The European Commission (EC) granted Sanofi approval for this obesity treatment in 2006, two years before FDA rejected it. FDA’s hostile review brought intense scrutiny of reports of intense depression and suicidal thoughts in association with the drug’s use. So the European agency found itself in the embarrassing position of withdrawing approval.
Regulators are human, too, and humans try not to repeat past mistakes. So when phentermine/topiramate (Qsymia) and lorcaserin (Belviq) came to the European Medicines Agency for approval, they were soundly rejected. Phentermine/topiramate was rejected twice. The hostile reception for lorcaserin led Arena to withdraw their application and avoid the embarrassment of a rejection.
Two things, really. To start, Europe is waking up to the fact that the rising toll of obesity is no longer just an American phenomenon. It’s gone global. Evidence-free, wishful thinking about prevention by itself is not solving the problem. People everywhere are getting more serious about evidence-based solutions — both treatment and prevention.
But just as important has been a shift in thinking, away from weight loss miracle drugs, and toward more serious therapeutics for the chronic disease of obesity. Both regulators and sponsors are realizing that these drugs should not be marketed as “diet pills.” Rather, everybody needs to get real about drugs that can be used in an integrated approach to improving the health status of people living with obesity.
We don’t have cures (yet) and benefits come with risks. Skilled obesity medicine physicians and their patients are now on their way to having more options. Opening the way for innovation in Europe — as well as in the U.S. — is a good step forward.
It looks like both bupropion/naltrexone and liraglutide for obesity treatment will gain final European approval and launch in 2015.
Europe, photograph © Niccolò Caranti / flickr
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