Vivus Hoping Weight Loss Drug Will Gain Approval as FDA Releases Briefing Documents
Today, the FDA released briefing documents for the upcoming FDA panel for Qnexa, a weight loss drug developed by Vivus (NASDAQ: VVUS). The company had previously received a CRL for the drug in 2010, as the FDA voiced concerns that the drug could have adverse effects in pregnant women, as well as patients with a history of heart problems. These issues have followed Vivus to the present, as the FDA has recommended that Vivus conduct a cardiovascular outcomes trial prior to Qnexa's approval.
A weight loss drug would have massive blockbuster potential in the US, as nearly two thirds of Americans are overweight. Qnexa's drug had already showed good efficacy data, as patients in clinical trials showed statistically significant weight loss. The drug is considered the leading candidate to be approved, with drugs from Arena Pharma (NASDAQ: ARNA) and Orexigen Therapeutics (NASDAQ: OREX) also with drugs in development.
There is clearly a need for a weight loss drug, given the obesity epidemic in America. However, the current pipeline of drugs has shown serious side effects that the FDA has considered. There is a high standard of safety to approval, and it remains to be seen whether these companies can generate enough funding while waiting for approval. Vivus appears to have the leading candidate, and investors will be watching the FDA panel on Wednesday closely to see if it recommends approval of Qnexa.
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