As we correctly predicted, Lorcaserin has won the vote of the Food and Drug Administration’s (FDA) advisory committee. Since the FDA usually goes with the advice of its panel and considering the vote swung in favour of the drug by 18-4 with one abstention, it looks likely that the approval will go ahead. Lorcaserin will be marketed as Lorqess.
It was said that Lorcaserin’s benefits outweighed the risks and the committee was happy with what it heard in relation to previous anxieties regarding heart valve damage and tumours in rats.
We expect to hear back from the FDA this June and we also anticipate that the European Medicines Agency will approve the drug by the end of 2012, following what we expect to be an approval in the States. EMA accepted the drug’s marketing authorisation application in March this year.
The drug will be manufactured by Arena pharmaceuticals in a plant in Switzerland and distributed and marketed by Eisai. We are keen to start prescribing this medication given the burgeoning problem of obesity and the paucity of options available to patients for whom diet and exercise simply do not work.