FDA to Review VIVUS Drug - Analyst Blog

Recently, VIVUS, Inc. (VVUS) announced that the New Drug Application (NDA) for its obesity candidate, Qnexa, will be reviewed by the Endocrinologic and Metabolic Drugs advisory committee of the U.S. Food and Drug Administration (FDA) tentatively on July 15, 2010. 

The US regulatory authority accepted the NDA filed by VIVUS for Qnexa on March 1, 2010. The NDA was filed in December 2009. A response from the FDA should be out in the fourth quarter of 2010 (action date: Oct 28, 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 on the fate of a drug candidate.
 
Qnexa is VIVUS’ lead pipeline candidate. It is a proprietary oral drug candidate that combines two previously approved products, topiramate and phentermine, to employ a dual mechanism to treat obesity. The drug is designed to address the excess appetite and high threshold for satiety that impact eating behavior. The full dose of Qnexa is a combination of 15mg phentermine and 92mg of a proprietary controlled release (CR) topiramate. Qnexa is being developed to treat other indications also. 

However, we note that VIVUS is not the only company seeking to develop a treatment for obesity. Companies like Amylin Pharmaceuticals, Inc. (AMLN), Arena Pharmaceuticals (ARNA) and Orexigen Therapeutics (OREX) are all striving to bring obesity treatments to the market. Lorcaserin of Arena Pharmaceuticals and Contrave of Orexigen Therapeutics are expected to hit the market at the same time as Qnexa. Arena filed for FDA approval in late 2009 and Orexigen is expected to do so this year. 

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 obesity affects over 400 million people globally. Moreover, 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 pipeline would help drive growth at VIVUS.
Read the full analyst report on "VVUS"
Read the full analyst report on "ARNA"
Read the full analyst report on "AMLN"
Read the full analyst report on "OREX"
Zacks Investment Research