Arena Pharmaceuticals (Arena) has submitted a New Drug Application (NDA) to the FDA for Lorcaserin, the company’s drug candidate for weight management, including weight loss and maintenance of weight loss.
Arena said that the submission is based on an extensive data package from Lorcaserin’s clinical development program that includes 18 clinical trials totaling 8,576 patients.
The phase 3 clinical trial program, Bloom and Blossom, evaluated nearly 7,200 patients treated for up to two years. It showed that Lorcaserin consistently produced significant weight loss with positive safety and tolerability.
William Shanahan, vice president and chief medical officer of Arena, said: “Physicians need new, better-tolerated approaches to improve the treatment of patients who are obese or significantly overweight.
“Based on the robust data package we submitted to the FDA, Lorcaserin has the potential to meet this need, offering patients the opportunity to achieve sustainable weight loss in a well-tolerated manner and improve their cardiometabolic health and quality of life.”
Jack Lief, president and CEO of Arena, said: “Today’s NDA submission is an important milestone towards realising Lorcaserin’s commercial potential, and we are excited by the possibility of bringing Lorcaserin to patients who need help in managing their weight. Physician feedback suggests that, if approved, Lorcaserin’s combination of efficacy, safety and tolerability will position the drug candidate as first-line therapy for weight management.”