FDA accepts Wyeth's Tygacil sNDA for review

US-based Wyeth Pharmaceuticals has reported that the FDA accepted its supplemental new drug application (sNDA) for first-in-class antibiotic Tygacil (tigecycline) for the treatment of patients with community-acquired pneumonia.

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 sNDA submission included integrated data from two investigational clinical studies involving 846 patients. Study data showed that Tygacil cured 89.7 per cent of patients hospitalised with community-acquired pneumonia (CAP), and levofloxacin, an existing treatment option for CAP, cured 86.3 per cent of studied patients.

The most common adverse events for Tygacil were nausea, vomiting and abdominal pain. The discontinuation rates due to adverse events for Tygacil and levofloxacin were similar, 6.1 per cent and 8.3 per cent, respectively.

The FDA approved Tygacil in June 2005 for use in hospital patients with serious bacterial infections, including those
resistant to most other antibiotics. The intravenous drug is used as a first-line treatment for stomach and skin infections and is effective against enough different bacteria to be used before doctors know which ones are causing the infection.

Gary Stiles, Wyeth's CMO, 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."

For Q3 FY07, Wyeth said that Tygacil hit the USD 100m mark and added that it was on track to meet its goal of doubling FY06 revenues, driven by US growth.