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news.Wyeth Pharmaceuticals has reported that the FDA has accepted its supplemental new drug application for first-in-class antibiotic Tygacil for the treatment of patients with community-acquired pneumonia.
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The agency will complete its review of the application and may approve or disapprove the application, request additional data or take other administrative actions.
The supplemental new drug application (sNDA) submission included integrated data from two investigational clinical studies that included 846 patients. Study data showed that Tygacil (tigecycline) cured 89.7% of patients hospitalized with community-acquired pneumonia (CAP), and levofloxacin, an existing treatment option for CAP, cured 86.3% of studied patients. The most common adverse events for Tygacil were nausea (24.3%), vomiting (16.0%) and abdominal pain (5.7%). The discontinuation rates due to adverse events for Tygacil and levofloxacin were similar (6.1% and 8.3%, respectively).
Gary Stiles, executive vice president and chief medical officer of Wyeth Pharmaceuticals, said: “Community-acquired pneumonia is a serious respiratory disease that affects millions of Americans. The acceptance of this sNDA is an important event as it brings Wyeth closer to providing physicians with a new option for the treatment of CAP.”