An FDA panel’s recommendation to approve VIVUS’s obesity drug Qnexa prompted the company’s shares to rise 85 percent in last week’s trading, an impressive jump that rewards the company for the “other” holy grail of pharmaceuticals: a safe, effective, weight loss drug.
The FDA decision is expected in April, upon which Qnexa will be the first weight loss drug the agency has approved in more than 10 years.
Qnexa is an updated formulation of phentermine, considered the “safe” part of fen-phen, the infamous drug combination that was implicated in heart valve failures. The resulting lawsuits changed the face of the $200 billion US pharmaceutical industry. And while phentermine is considered safe, the list of Qnexa side effects is sobering: increased heart rate, memory loss, and birth defects, in particular cleft palates, are just some of the downsides.
However, the drug is effective at helping obese patients lose up to 10 percent of their body weight, no small feat. VIVUS has said it will put safeguards in place to prevent pregnant women from taking the drug; women of childbearing age will likely have to take routine pregnancy tests.
The fact that even the risk of birth defects was not enough to get a thumbs down from the panel is an indication of how obesity has become a major problem in the US. An estimated 33 percent of adults in the US is considered obese, according to the Centers for Disease Control, increasing health care costs due to heart disease, diabetes, and other health problems. An effective weight loss drug, even one that can promise only a 10 percent reduction in body weight, could help reduce those costs.
Last fall I wrote about a handful of companies that were introducing their own weight loss drugs. Qnexa may be the first of a wave of new, safer, products that will be scrutinized closely by the health care industry, patients — and investors.