FDA News

FDA Accepts Wyeth's Supplemental New Drug Application for Tygacil

(Oct 23, 2007)-- Wyeth Pharmaceuticals, a division of Wyeth , announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's supplemental New Drug Application (sNDA) for its first-in-class antibiotic Tygacil (tigecycline) for the treatment of patients with community-acquired pneumonia (CAP). The FDA now will complete its review of the application. The FDA may approve or disapprove the application, request additional data or take other administrative actions.

"CAP is a serious respiratory disease that affects millions of Americans," says Gary L. Stiles, M.D., Executive Vice President, Chief Medical Officer, Wyeth Pharmaceuticals. "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."

The sNDA submission included integrated data from two investigational clinical studies that included 846 patients. Study data showed that Tygacil cured 89.7 percent of patients hospitalized with CAP, and levofloxacin - an existing treatment option for CAP - cured 86.3 percent of studied patients. The most common adverse events for Tygacil were nausea (24.3 percent), vomiting (16.0 percent) and abdominal pain (5.7 percent). The discontinuation rates due to adverse events for Tygacil and levofloxacin were similar (6.1 percent and 8.3 percent, respectively).

"As antibiotic resistance continues to be a concern for many strains of the most common bacteria causing CAP, there is a growing need for new options," says Thomas File, M.D., Chief of Infectious Disease Services for Summa Health System in Akron, Ohio.

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