History is a strange beast. You can only see it when you turn and look back. The closer it is to you, the less easy it is to see. The difficulty with writing about acomplia is that you must always start somewhere. Wherever you pick in time, the real question is how far back to look. What have we taken for granted? What gaps have we left? So in this article, we catch up with the past. Just to make sure that we have everyone on the same virtual page.
Acomplia (generic name rimonabant) has been an authorised medication in the EU since June 2006 for use in adult patients where the BMI exceeds 30 or the BMI exceeds 27 with associated risk factors such as diabetes. In all cases, it can only be prescribed in conjunction with a hypocaloric diet and physical exercise.
2007 was quite a good year. In March, the French government announced that acomplia was the first selective cannabinoid-1 receptor antagonist to be reimbursable by Social Security. Patients with prescriptions are entitled to recover 35% of the cost. The fact that no other medication has been approved for the subsidised treatment of obesity, gives acomplia a big market advantage in France.
In April, the Swiss government followed suit, placing acomplia on the mandatory reimbursement list both for the treatment of patients with type 2 diabetes with a BMI of 28 or more, and for the treatment of any patient with a BMI greater than 35.
But acceptance was not limited to Europe. April also saw an announcement from the Brazilian government that acomplia can be marketed to patients with a BMI over 30 or greater than 27 where there are risk factors present.
In July, the European Medicines Agency (EMEA) modified its blanket approval for acomplia. It formally accepted evidence that there may be psychiatric side effects and so issued a directive that acomplia should not be prescribed to patients who have been diagnosed with major depression or who are already receiving antidepressants. In one sense, there was nothing new about this because the risk was identified when approval was first given in June 2006. But the EMEA's Committee for Medicinal Products for Human Use (CHMP) changed the level of warning.
The CHMP holds a general brief for monitoring the safety of medicines licensed for use in the EU. In June, it therefore requested Sanofi-Aventis, the French manufacturer, to submit all the available data it had in its possession on these side effects. In July, it concluded that the benefits of using continued to outweigh the possible disadvantages except in the cases where a patient was more seriously depressed. Thus, the warning now directs doctors either not to prescribe acomplia where a patient has been diagnosed as severely depressed, or to discontinue the use of acomplia if a patient subsequently becomes depressed. By publicising its findings, the CHMP was also taking steps to alert patients and their carers of the potential risk of using acomplia in relation to depression.
In November, the European Commission accepted EMEA's positive impression of acomplia, reacting favourably to the results of the SERENADE study (Study Evaluating Rimonabant Efficacy in Drug-NAive DiabEtic Patients), in which newly diagnosed type 2 diabetic patients showed significantly improved glycemic control and a reduction in cardio-metabolic risk factors.
It is important to recognise that SERENADE is part of a more extensive Phase IIIb clinical trial program being carried out round the world. At present, there are more than 25,000 participants in eight further studies to study the effect of acomplia in the treatment of type 2 diabetes. These results are expected during the next two years.
