Wyeth Pharmaceuticals, a division of Wyeth, announced that the US Food and Drug Administration (FDA) has issued an approvable letter for the first-in-class antibiotic Tygacil (tigecycline) for the treatment of adult patients with community-acquired pneumonia (CAP).
Before granting approval, the FDA requested that Wyeth provide additional analyses to support the safety and efficacy of Tygacil for the treatment of patients with CAP with illness severe enough to require hospitalization, including those who are at higher risk of mortality.
In addition, the FDA requested information regarding the benefit/risk of Tygacil for any potential of liver toxicity. Wyeth recently provided that information to the agency during the review period and believes that its response adequately addresses the issues raised by the FDA. However, the agency acknowledged in its letter that it had not yet reviewed that information.
"We believe the data from our current clinical development program support Tygacil as a potential therapeutic option for patients with CAP," says Gary L. Stiles, M.D., executive vice president, chief medical officer, Wyeth Pharmaceuticals. "Wyeth is committed to working with the FDA to resolve the outstanding issues for Tygacil in order to gain approval."
Tygacil was approved by the FDA in June 2005 for the treatment of adult patients with complicated intra-abdominal infections (cIAI) and complicated skin and skin structure infections (cSSSI).
Wyeth has achieved significant success in bringing new products to market. Year to date, the Company has obtained three new product approvals in the following therapeutic areas: major depressive disorder, Haemophilia A and opioid-induced constipation.