Vivus Turned Down by FDA

Vivus (NASDAQ: [[ticker:VVUS]]), the Mountain View, CA-based obesity drug developer, failed to win FDA clearance to start selling its combination drug in the U.S. The agency, in a complete response letter to the company, requested a “comprehensive assessment” on whether the Vivus therapy, a combination of phentermine and topiramate (Qnexa), is linked to birth defects or miscarriages. The company said it plans to respond to the FDA’s questions in writing in about six weeks. The rejection is no big surprise, given that an FDA advisory panel in July recommended the application be turned down, and the FDA this month rejected the application of another obesity drugmaker, San Diego-based Arena Pharmaceuticals (NASDAQ: [[ticker:ARNA]]).

Author: Luke Timmerman

Luke is an award-winning journalist specializing in life sciences. He has served as national biotechnology editor for Xconomy and national biotechnology reporter for Bloomberg News. Luke got started covering life sciences at The Seattle Times, where he was the lead reporter on an investigation of doctors who leaked confidential information about clinical trials to investors. The story won the Scripps Howard National Journalism Award and several other national prizes. Luke holds a bachelor’s degree in journalism from the University of Wisconsin-Madison, and during the 2005-2006 academic year, he was a Knight Science Journalism Fellow at MIT.