The US Food and Drug Administration (FDA) has approved Oscient Pharmaceuticals' Factive (gemifloxacin mesylate) tablets for the five-day treatment of community-acquired pneumonia of mild to moderate severity (CAP).
The approved supplemental New Drug Application (sNDA) was based on the results of the Company's successful phase III trial in 510 CAP patients comparing a five-day treatment and the originally approved seven-day treatment with Factive 320 mg once-daily. Oscient first launched Factive for the seven-day treatment of CAP and the five-day treatment of acute bacterial exacerbations of chronic bronchitis (AECB) in the fall of 2004. To date, approximately one million patients worldwide have been treated with Factive.
"More and more, research and clinical experience is demonstrating the importance of short courses of potent antibiotic therapy in treating community-acquired pneumonia, as recommended in the CAP treatment guidelines from the Infectious Diseases Society of America and the American Thoracic Society," stated Thomas File, M.D., Professor of Internal Medicine and Head of the Infectious Disease Section, Northeastern Ohio Universities College of Medicine and an investigator in the five-day CAP clinical trial. "The availability of five-day Factive for CAP will allow patients access to effective short course therapy that may improve patient convenience while potentially lowering the risk for bacterial resistance and adverse events."
"A key goal for Oscient has been to pursue short course therapy with Factive in all of our licensed territories and Factive is now the only fluoroquinolone approved in the US for the five-day treatment of both AECB and CAP," stated Steven M. Rauscher, President and Chief Executive Officer. "With this approval, physicians now have access to an important option for treating lower respiratory tract infections with a convenient, short course treatment regimen."
According to the new label, Factive is approved for the five-day treatment of CAP caused by Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Chlamydia pneumoniae. Factive remains approved for the treatment of CAP caused by multi-drug resistant Streptococcus pneumoniae, Klebsiella pneumoniae or Moraxella catarrhalis with a duration of therapy of seven days. The clinical trial comparing the five-day and seven-day course of treatment yielded strong clinical response rates at follow-up (the primary endpoint) in the per protocol group: 95% in the five-day arm and 92% in the seven-day arm. Community-acquired pneumonia is a common and serious illness in the United States with an estimated four to five million cases per year, one million of which occur in patients over the age of 65. CAP cases result in approximately 10 million physician visits and as many as one million hospitalizations annually. Factive is also approved for the five-day treatment of AECB due to Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.