As we trailed in our blog yesterday, Arena Pharmaceuticals has filed a New Drug Application (NDA) with the European Medicines Agency (EMA) for their weight loss treatment, Lorcaserin. Arena does not yet know if the agency will accept the filing of its application but will find out later this month. We understand that Lorcaserin will be marketed as Lorqess.
The drug will be suitable for those who are overweight and have a BMI of over 27 and who have one or more co-morbid conditions as a result of their overweight status and those who are clinically obese with a BMI of over 30.
The company submitted an NDA to the Food and Drug Administration (FDA) some months ago and it was accepted. We are set to have an update on its progress with the FDA this June. Having had their NDA rejected in 2010 by the FDA based on the fact that tumours were reported during animal studies, the pharmaceutical company has conducted further studies to demonstrate the safety of this product. Unlike Qnexa, which is also being scrutinised by the EMA, Lorcaserin is an entirely new molecule so there is no track record outside the sphere of the clinical trials.