The US Food and Drug Administration (FDA) has accepted as complete Oscient Pharmaceuticals Corporation's response to the Factive (gemifloxacin mesylate) tablets approvable letter for the application seeking approval for the five-day treatment of community-acquired pneumonia of mild to moderate severity (CAP).
Factive is currently approved by the FDA for the five-day treatment of acute exacerbations of chronic bronchitis (AECB) and the seven-day treatment of CAP.
The approvable letter, received on September 21, 2006, asked for clarification and additional interpretation regarding certain data included in the application to assist the FDA in its evaluation. Oscient submitted its response to the approvable letter last month. The FDA has classified the complete response as a Class II resubmission with a user fee deadline of May 1, 2007.
"We are looking forward to working with the FDA through this final phase of review of our five-day CAP application," stated Steven M Rauscher, president and CEO.
The NDA for the five-day treatment of CAP contained data from a successful phase III trial completed in 2005 comparing a five-day and seven-day treatment with Factive 320 mg once-daily for CAP in 510 patients. That study demonstrated strong clinical response rates at follow up (the primary endpoint) 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, resulting in approximately one million hospitalisations and 40,000 deaths annually.
Pneumonia is the most common cause of death due to an infectious disease.
Oscient Pharmaceuticals Corporation is a commercial-stage biopharmaceutical company marketing two FDA-approved products with its national primary care sales force. Antara 130 mg (fenofibrate) capsules are indicated for the adjunct treatment of hypercholesterolemia (high blood cholesterol) and hypertriglyceridemia (high triglycerides) in combination with diet.
Factive (gemifloxacin mesylate) tablets are an antibiotic approved for the treatment of acute bacterial exacerbations of chronic bronchitis and community-acquired pneumonia of mild to moderate severity. Oscient also has a novel, late-stage antibiotic candidate, Ramoplanin, under investigation for the treatment of Clostridium difficile-associated disease (CDAD).