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news.The FDA has asked Oscient Pharmaceuticals to provide additional information to support its application for pneumonia drug Factive. The company said that no new clinical trials are required.
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Oscient is seeking approval to use Factive for five-day treatment of community-acquired pneumonia (CAP). Factive is currently approved for the five-day treatment of acute bacterial exacerbations of chronic bronchitis (AECB) and the seven-day treatment of CAP.
According to the FDA approvable letter, the company is required to provide clarification and additional interpretation regarding certain data included in the application to assist the FDA in its evaluation.
Oscient said that it would provide this information to the FDA in the coming weeks and that it believed no additional clinical trials were required.
The submission for the five-day treatment of CAP contained data from a successful phase III trial completed in 2005. Currently, no fluoroquinolone is approved for the five-day treatment of both AECB and CAP.
Community-acquired pneumonia is a common and serious illness in the US with three to four million cases per year, resulting in approximately one million hospitalizations and 40,000 deaths annually.