US FDA advisories say no to Arena/Eisai's obesity drug lorcaserin; back new use for Alkermes' Vivitrol

The US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee yesterday voted nine to five against approval of Arena Pharmaceutical (Nasdaq: ARNA) and Japanese drugmaker Eisai’s (TYO: 4523) obesity drug lorcaserin, sending the US firm’s shares tumbling 43% to $2.14 and casting another blow for weight loss products.

The negative decision comes just a day after a split vote by the same panel on whether or not to keep Abbott Laboratories currently marketed obesity drug Meridia (sibutramine) on the market and following a negative vote on Vivus’s Qnexa (phentermine/topiramate) earlier this year (The Pharma Letter September 16 and July 16).

The panel said that the available data do not adequately demonstrate that the potential benefits of lorcaserin outweigh the potential risks, when used long-term in a population of overweight and obese individuals to allow marketing approval. Lorcaserin, which Arena discovered and has developed, is intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese (Body Mass Index, or BMI, >30) or patients who are overweight (BMI >27) and have at least one weight-related co-morbid condition.