On the day after an EU court ruled that obesity can be considered a disability in some instances, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of the first new weight-loss agent for many years, prolonged-release naltrexone/bupropion (Orexigen Therapeutics/Takeda).
If approved, which is normally a formality within 2 months, the combination will be known as Mysimba and will be available for weight management in adults with a body mass index (BMI) of 30 kg/m2 or greater (obese) or a BMI of 27 kg/m2 to <30 kg/m2 (overweight) in the presence of one or more complications related to weight, such as type 2 diabetes, hypercholesterolemia, or hypertension.
Mysimba will need to be used in addition to the adoption of a reduced-calorie diet and physical activity, and patients will need to be evaluated 16 weeks after beginning therapy; if they have not lost at least 5% of their body weight, treatment should be stopped.
European Doctors Will Welcome Decision
The decision is likely to be welcomed by physicians treating obesity in Europe, who have long bemoaned the fact that they have not had access to any of the newer agents for weight loss that are available in the United States. Earlier this year, the European Association for the Study of Obesity (EASO) called attention to this issue at its annual meeting.
Asked to comment, Dr Matt Capehorn (clinical director of the UK National Obesity Forum) said: "We're not reliant on weight-loss pharmacotherapy as the answer to everyone's problems, but it is one part of the solution. We can't offer a disciplinary team approach without the help of weight-loss medications as part of it, and we have struggled recently, only having one available drug."
Currently, the only obesity drug on the market in Europe is orlistat, which is available without a prescription in a low dose (Alli, GlaxoSmithKline) or by prescription at a higher dose (Xenical, Genentech).
"Some patients don't tolerate orlistat or don't like it, so the fact that we are now going to have another agent available is very good and should be welcomed," Dr Capehorn told Medscape Medical News.
"Obviously, we need to be very careful that it's prescribed appropriately by healthcare professionals who can select the right patient and counsel them with regard to side effects," he noted.
And, he said, "Personally, I would like to see it prescribed only within tier 3 weight-management clinics [specialist obesity centers in the UK], rather than being able to be broadly prescribed by any general practitioner."
"We know what pressure GPs are under when a patient comes in and says, 'Please give me this new weight loss drug that's been on the front page of the Daily Mail [a UK tabloid newspaper]," he added.
Interim Results on CV Outcomes With Mysimba "Reassuring"
The path to approval for bupropion/naltrexone has been far from straightforward; the US Food and Drug Administration (FDA) first rejected the drug combination in 2011, asking the company to conduct a cardiovascular-outcomes trial because of concerns about the cardiovascular safety profile of the agent when used long term in a population of overweight and obese subjects.
Orexigen Therapeutics subsequently began the 8900-patient Light Study and, following encouraging interim safety and outcomes data from this trial, the company resubmitted the US new drug application at the end of last year; the drug was approved there in September.
It appears that these data have also been sufficient to convince the EMA to recommend approval of the agent: "Interim results from an ongoing cardiovascular-outcome trial were reassuring in terms of risk of serious cardiovascular disease related to treatment with Mysimba," it notes. "A second study is planned to continue monitoring longer-term cardiovascular safety with the medicine."
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Cite this: EU Finally Gives Green Light to New Obesity Drug - Medscape - Dec 19, 2014.