The Food and Drug Administration (FDA) has released a Complete Response Letter to Arena Pharmaceuticals declining an immediate approval for the weight drug lorcaserin.
(prHWY.com) December 12, 2011 - Canoga Park, CA -- The Food and Drug Administration (FDA) has released a Complete Response Letter to Arena Pharmaceuticals declining an immediate approval for the weight drug lorcaserin.
On September 16th, an FDA advisory committee had voted to recommend against approval of lorcaserin based on fears over both safety and efficacy.
Two of the main issues the FDA have with lorcaserin were weight-loss results that failed to meet FDA standards for approval, and an increase in cancerous breast and brain tumors in rats which were given a dose of the drug that is higher than that proposed for humans.
Lorcaserin, according to the company, is designed for weight-loss and weight-loss maintenance in "obese patients or patients who are overweight and have at least one weight-related co-morbid condition."
A clinical trial of Lorcaserin issued in the New England Journal of Medicine determined that two-thirds of patients lost at least 5% of their body weight, while a third lost at least 10%, with an average loss of 17 to 18 pounds.
An FDA letter to Arena talked about the need for more positive data on lorcaserin's long-term efficacy and concerns about an early study on rats that showed breast-tumor growth among the females, the company said.
Arena, and Eisai, Inc., its development partner for lorcaserin, said they will meet with the FDA to discuss the agency's requests and determine the future path for lorcaserin.
"We intend to meet with the FDA to obtain further clarity on the approval path and timeline," said Jack Lief, Arena's president and chief executive. "We will work with the agency to address the issues with our [new drug application] as quickly as possible."
Lorcaserin rejection is the latest in a chain of bad news for diet drugs in United States. Arena is in a three-way race with Orexigen Therapeutics Inc. and Vivus Inc. to sell a new weight-loss pill. Orexigen 's pill Contrave, is one last experimental weight loss drug that will come before FDA advisers for approval on 7th December.
For more details, please contact:
101 Medical Weight Loss
Communication Dept
22030 Sherman Way, Suite # 101, Canoga Park, CA 91303
Tel: 818-312-9595
Fax: 818-312-9100
Visit Us:
http://www.101medicalweightloss.com/
###