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Wyeth Pharmaceuticals – a division of Wyeth – announced today that it is withdrawing its application for an extension to the European Marketing Authorisation for TYGACIL (tigecycline).
This extension sought approval of TYGACIL for the treatment of community-acquired pneumonia (CAP). Wyeth’s action is based on its understanding of the Committee for Medicinal Products for Human Use (CHMP) assessment that the TYGACIL community-acquired pneumonia (CAP) pivotal clinical trials did not include a sufficient number of severely ill CAP patients to alleviate reviewer concerns regarding efficacy in this subpopulation.
TYGACIL is currently approved in Europe for the treatment of complicated intra-abdominal infections and complicated skin and soft tissue infections in adults.
“We are disappointed that we were not able to allay the concerns of the CHMP, and are evaluating the appropriate next steps to take in Europe,” says Gary L Stiles, MD, Executive Vice President and Chief Medical Officer, Wyeth Pharmaceuticals.
“In October 2007, the US Food and Drug Administration (FDA) accepted the filing of our supplemental New Drug Application for TYGACIL for the treatment of patients with CAP. We believe that the clinical trial data submitted to the FDA, as well as other regulatory authorities around the world, demonstrate the safety and efficacy of TYGACIL for the proposed CAP indication.”
The FDA is currently reviewing this application and a decision is expected during the second quarter of 2008. TYGACIL has been approved for use in patients with CAP in the Philippines and Thailand. Regulatory applications are also pending in Australia, Brazil, Canada, Switzerland and India.
