Image via Wikipedia The U.S. Food and Drug Administration has refused to recommend the Vivus Inc (NASDAQ: VVUS) diet drug Qnexa for approval. Citing multiple safety concerns, the panel narrowly rejected recommending the pill, which studies had shown to be effective in helping overweight people lose weight. While the FDA is not bound to the recommendations of its panels, it follows them most of the time.
Shares of Vivus had been bid up considerably in recent months in anticipation of Qnexa's approval. Vivus shares did not trade Thursday pending the outcome of the meeting. You can expect shares of Vivus to get hammered tomorrow on this outcome. I and many others did not see this coming.
Unfortunately, the panel believes that obesity is not life threatening, so why approve a drug that could cause complications. It is a modified fen-phen and we all should have seen this coming. I don't know why I didn't believe my own cautious approach. Oh well, that's investing in the BioPharma market.
From Fierce Biotech: BREAKING NEWS: Panel not convinced by Vivus' Qnexa
July 15th, 2010
GAITHERSBURG, MD -- Expressing the need for more information--especially about teratogenicity--an FDA expert panel has recommended against approval of Vivus' (NASDAQ: VVUS) obesity drug Qnexa. The vote was six in favor and ten against, with many of the no voters citing the need for more safety data.
During the meeting, several of patients shared their experiences with Qnexa after taking the drug during clinical trials. They asked the committee to approve the drug, pointing to the success they had experienced, and their stories led to audience applause. However, Public Citizen's Sidney Wolfe expressed concern about safety issues, citing the lack of longer-term data, as well as the potential for fetal exposure during pregnancy. He also called it a mere "repackaging of two old drugs," and urged rejection.
But many panelists had problems with the lack of long-term clinical data on the drug. For example, one of the patients who spoke had regained much of the weight she had lost after coming off the drug. This would indicate that patients would need to take the drug over a long period of time--perhaps for the rest of their lives. Panelist Lamont Weide said that while was glad to see that obesity is being treated as a chronic disease, it would require doctors to look at what will happen to patients in the longer term.
Perhaps one of the biggest concerns was possible teratogenic risks, as women of reproductive age would turn to this drug. The sponsor had said it include labeling that Qnexa shouldn't be used if a woman is pregnant or is thinking of becoming pregnant, but many of the panelists were still concerned about reproductive risks.
Another panelist cited the potential effects like depression and memory problems--to him, there wasn't enough data to say whether this is a problem. Acting Chair Kenneth Burman voted no, citing cognitive issues, renal problems, and the lack of long-term data. But if it is approved, it should be tightly regulated--including the use of a registry. He could have voted yes, however, if potential problems for specific populations, including pregnant women, had been addressed.