Arena Pharmaceuticals must be very pleased with themselves since their application for weight loss treatment, Lorcaserin, was resubmitted and accepted by the Food and drug Administration in the US. The company has also completed a new round of fundraising, which amounted to $33 million.
The original New Drug Application for Lorcaserin had been rejected in 2010. The company has provided further information to the regulator in accordance with its requests regarding concerns that tumours were observed in animal studies. The company’s response to the regulatory body included certain results from their phase III trial, which had not been detailed in the previous application and which outlined study material on the use of Lorcaserin with type-2 diabetes patients.
It is anticipated that the FDA will give a final opinion on Lorcaserin on 27th June 2012. Meanwhile, we understand that Lorcaserin will be submitting an application to the European Medicines Agency in the next few months.