FDA Panel for Arena Obesity Drug – Analyst Blog

Recently Arena Pharmaceuticals Inc. (ARNA) announced that its New Drug Application (NDA) for lorcaserin, the company’s candidate for weight management, including weight loss and its maintenance, will be scrutinized by the Endocrinologic and Metabolic Drugs advisory committee of the US Food and Drug Administration (FDA) tentatively on September 16, 2010.

 

The NDA was filed in December 2009. The submission of the application was based on a data package from lorcaserin’s development program, which included 18 clinical trials involving 8,576 patients. A response from the FDA should be out in the fourth quarter of 2010 (action date: October 22, 2010). Even though the US agency is not bound to follow the advice of its advisory committees, the recommendation of the panel is usually considered by the agency while deciding the fate of a drug candidate.

 

Lorcaserin has been discovered and developed by Arena. The candidate aims to treat overweight patients suffering from at least one weight-related co-morbid condition. Lorcaserin would be Arena’s first drug to hit the market if the US agency approves.

 

However, we note that Arena is not the only company seeking to develop a treatment for obesity. Companies such as Amylin Pharmaceuticals Inc. (AMLN), Orexigen Therapeutics Inc. (OREX) and VIVUS Inc. (VVUS) are all striving to bring obesity treatments to market. Orexigen’s Contrave, VIVUS’ Qnexa as well as Arena’s lorcaserin work by affecting the patient’s central nervous system, thereby dampening the appetite.

 

While the NDA for Contrave was accepted recently by the FDA, Qnexa is scheduled to be reviewed by an advisory panel of the US agency tentatively on July 15, 2010. The target date for Qnexa is October 28, 2010. Furthermore, recently, Amylin Pharmaceuticals and partner Takeda Pharmaceutical Co. Ltd. announced that they intend to advance their obesity combination treatment of pramlintide and metreleptin into late-stage studies.

 

Obesity is an attractive market that could be worth many billions of dollars. It is estimated that over 400 million people are affected by obesity globally. Obesity is linked to increased health risk of several medical conditions. Given the huge unmet need in this market, the successful development of the obesity candidate would help drive growth at Arena.