Mysimba Recommended for Approval
As has been the case for a number of years now, obesity treatments beyond invasive bariatric surgeries are non- existent. There is however a glimmer of hope in the form of Mysimba which has been recommended for approval by the European Medicines Agency (EMA) who have recommended that the drug be granted a marketing authorisation for the purpose of weight management in overweight and obese adults who also suffer one or more weight related conditions such as high cholesterol, blood pressure or type 2 diabetes. Studies gleaned that more patients taking the drug, who were simultaneously leading a healthier lifestyle regarding diet and exercise, achieved significant weight loss as compared to those who were treated with a placebo. All of this has happened only a few months after the drug gained approval in the States under the name, Contrave.
Mysimba is a combination drug containing both naltrexone, a drug designed to prevent drug dependence, and bupropion, an antidepressant, and is taken orally. The drugs in combination will focus on the areas of the brain responsible for the control of food intake, the associated reward pathways, and energy expulsion. Four impressive studies have been carried to prove its safety and efficacy with great results.
At the studies’ outset, the main concerns surrounding safety were central nervous system related and gastrointestinal related. Furthermore, longer-term cardiovascular outcomes have not been assessed. A second cardiovascular risk study has been planned as a result, but, the interim study, assessing risk of serious cardiovascular issues from the use Mysimba, was reassuring in the meantime.
The Committee for Medicinal Products for Human Use (CHMP), recommended that those who start the drug be assessed after the first 16 weeks. At this point, if the patient has not lost 5% or less of their starting weight, treatment should be ceased. Their recommendations are positive and will be sent to the European Commission so that they can make a decision on an EU marketing authorisation. The study’s results are promising enough to suggest this might be a very real possibility of this being available on prescription in the EU in the near future.
There are more options in the States than here, with four prescription treatments on the market now where, up until 2 years ago, there were none. The brands include, Qsymia (Vivus), Belviq (Arena), Xenical (Roche) and now Mysimba (Orexigen). Most of the drugs that did not make it here in Europe and were denied approval based on concerns regarding their safety profile. Decisions such as these tend to take approximately three months, so it will not be long before we know the fate of this new weight loss treatment.
There is one UK online that has already announced that it will be prescribing Mysimba as soon as it is finally approved and launched in the UK. You can find out more information about this at this website – www.theonlineclinic.co.uk
If you would like to read more about the European Medicines Agency recommendation Mysimba, you can pick up more details here.
For UK launch details, please see this website.