Arena files complete response on lorcaserin

In another attempt to gain approval for its obesity drug candidate that was turned down by US regulators (The Pharma Letter October 25, 2010), Arena Pharmaceuticals (Nasdaq: ARNA) has submitted its response to the Complete Response Letter (CRL) issued by the US Food and Drug Administration following review of the lorcaserin (proposed trade name Lorquess) New Drug Application.

Arena’s shares leapt 14.6% to $2.20 in late trading on the news, but the stock is still well below the $8 at which it was trading ahead of the FDA’s initial rejection of the lorcaserin NDA.

Lorcaserin, under development with Japanese drug major Eisai (TYO: 4523) that could earn the US firm as much as $1.37 billion, 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. The companies expect that later this month the FDA will confirm acceptance of the response and assign a new Prescription Drug User Fee Act (PDUFA) date.