|Arena shares up after presenting lorcaserin data [updated]|
|By Staff and Wire Reports|
|Thursday, 26 May 2011 08:56|
Lazard Capital Markets analyst William Tanner said Arena's presentation does not change his view that lorcaserin will not be approved, however.
"The overriding question is, `Are they going to be able to convince the FDA that there is no risk for lorcaserin treatment leading to cancer?'" he said. "I just don't think the FDA's going to approve the drug." Arena Pharmaceuticals plans to submit seek marketing approval in Europe next year.
Lorcaserin is an investigational drug candidate intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese (BMI >30) or patients who are overweight (BMI >27) and have at least one weight-related co-morbid condition.
"There is a significant unmet need for effective treatment options that can help patients reduce their weight and improve their health in a well-tolerated manner," said William R. Shanahan, M.D., Arena's Senior Vice President and Chief Medical Officer. "A diverse group of patients received lorcaserin in our Phase 3 program and achieved clinically meaningful weight loss and improvements in important cardiovascular and metabolic parameters."
Christen M. Anderson, M.D., Ph.D., Arena's Vice President, Lorcaserin Development, stated, "We are pleased to have the opportunity to share and discuss the results from the lorcaserin Phase 3 program with the European medical community at ECO, and we look forward to submitting a Marketing Authorization Application for regulatory approval of lorcaserin in Europe next year."
The three lorcaserin Phase 3 trials randomized a total of 7,794 patients, and 7,500 patients were included in the primary efficacy analyses (MITT-LOCF), which required a patient to have taken at least one dose of study medication and have had at least one weight measurement subsequent to baseline. The MITT-LOCF analyses included 3,349 lorcaserin 10 mg BID patients, 865 lorcaserin 10 mg QD patients and 3,286 placebo patients. Patients had an average BMI, baseline weight and age of approximately 36 kg/m2, 100 kg and 45 years, respectively; approximately 80% of patients were female.
Arena submitted a New Drug Application (NDA) for lorcaserin to the US Food and Drug Administration (FDA) in December 2009, and the FDA issued a Complete Response Letter (CRL) in October 2010. Arena is engaged in activities to address the issues raised by the FDA as part of its plan to submit a response to the CRL.