Arena Pharmaceuticals has received the news they were dreading. The FDA in the United States has rejected their obesity drug, Lorcaserin. The drug that presented before the panel in September, has failed to pass safety and efficacy standards of the organization. FDA announced that they were concerned about tumours found in the rats that were tested in the clinical trials and additionally, they described the drug as having limited benefits.
All of the mammary and lung tissues will now need to be looked at again and it must then be proved that the carcinogenicity of the drug would have an irrelevance in relation to a human risk assessment.
It may not be over for Lorcaserin if they can and will resubmit and disprove the concerns of the FDA regarding the efficacy of the drug.