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Oscient seeks FDA OK for Factive to treat pneumonia, FDA refuses sinusitis application
By Angela McDaniels
Seattle, Jan. 20 - Oscient Pharmaceuticals Corp. said the Food and Drug Administration has accepted for filing the company's supplemental New Drug Application seeking marketing approval for the use of Factive (gemifloxacin mesylate) 320 mg once-daily tablets for the five-day treatment of mild to moderate community-acquired pneumonia.
The FDA refused, however, to accept a similar application for the five-day treatment of acute bacterial sinusitis. The agency said Factive did not exhibit an acceptable risk versus benefit profile for the acute bacterial sinusitis indication, according to a company news release.
The FDA also said that demonstrating an acceptable risk versus benefit profile for Factive in this indication was not feasible, given the FDA's view of the potential risk of rash in patients with acute bacterial sinusitis.
"We have worked diligently with the FDA to compile an application that included supplemental clinical data and post-marketing safety reports, as well as a commitment to conduct additional post-approval surveillance," president and chief executive officer Steven Rauscher said in the release.
"We will continue to pursue short-course indications and will discuss with the FDA potential paths that would allow us to file for the acute bacterial sinusitis indication."
The FDA has granted a standard 10-month review period for the five-day community-acquired pneumonia application and will likely act on the filing by the end of September 2006. Oscient noted that the acceptance of the application does not assure approval.
Factive is approved by the FDA for the five-day treatment of acute bacterial exacerbations of chronic bronchitis and the seven-day treatment of mild to moderate community-acquired pneumonia.
Oscient is a biopharmaceutical company based in Waltham, Mass., that develops and commercializes therapeutics to address unmet medical needs.
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