The FDA asked for clarification and additional interpretation regarding certain data included in the application to assist in its evaluation. Oscient submitted its response to the approvable letter in October.
Factive is currently approved by the FDA for the five-day treatment of acute exacerbations of chronic bronchitis and the seven-day treatment of community-acquired pneumonia (CAP).
The new drug application for the five-day treatment of CAP contained data from a successful phase III trial completed in 2005 that compared a five-day and seven-day treatment with Factive once-daily for CAP. That study demonstrated strong clinical response rates at follow up in both arms.
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.