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.
Gary Stiles, executive vice president and chief medical officer, Wyeth Pharmaceuticals, said: “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. In October 2007, the 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.”