The race is on for the most effective and safest anti-obesity drug. Abbott, the makers of Meridia (Sibutramine) and Arena, the makers of Locaserin, are going head to head in September at the FDA in the US. Abbot will present to an advisory panel of the US Food and Drug Administration who will be reviewing on-going post-authorization clinical studies into the controversial drug Sibutramine on September 15th. The following day, the same panel will review the clinical data on new drug candidate, Lorcaserin.
Sibutramine, also known as Reductil, was only taken from the shelves in January after the European Medicines Agency (EMA) recommended its suspension after a 6 year study which revealed that patients taking Sibutramine showed an increase in the risk of non-fatal cardio vascular events where there was a pre-existing cardiovascular problem. The problem with this study was that it concentrated on a population group actually contraindicated for sibutramine under the terms of its marketing authorisation, leading many experts to criticise the decision of the EMA. Abbott is confronting the regulators again and is hoping to generate a different sort of recommendation.
The Endocrinologic and Metabolic Drugs Advisory Committee will review Lorcaserin just one day after Abbott’s meeting with the FDA. It is anticipated that the result for Loracserin will be positive given that it appears to meet the benchmark criteria in terms of weight loss and the side effects appear to be minor. Also, unlike Qnexa, which got the thumbs down last month, Lorcaserin has been studied over two years. Lorcaserin, in its phase III of clinical testing, triumphed when 7% of both the Lorcaserin users and the placebo users stopped taking the treatment due to the experiencing of uncomfortable side effects. Lorcaserin has the lowest discontinuation rates of any anti-obesity treatment.
Whilst we desperately need new treatments to help with the burgeoning problem of obesity, we need to make sure that the risks associated with taking any new drug do not outweigh the benefits.