Wyeth's Tygacil gets FDA "appro" letter

US drug major Wyeth says that the Food and Drug Administration has issued an "approvable" letter for the first-in-class antibiotic Tygacil (tigecycline) for adult patients with community-acquired pneumonia.

Before granting approval, the agency requested that Wyeth provide additional analyses to support the safety and efficacy of the drug 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 asekd for 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 agency. However, the latter acknowledged 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," said Gary Stiles, chief medical officer of Wyeth Pharmaceuticals. "Wyeth is committed to working with the FDA to resolve the outstanding issues for Tygacil in order to gain approval," he added. Tygacil was approved by the US regulator in June 2005 for the treatment of adult patients with complicated intra-abdominal infections and complicated skin and skin structure infections.