Wyeth pulls Europe application for pneumonia drug

LOS ANGELES, April 23 (Reuters) - Wyeth Pharmaceuticals, a unit of Wyeth WYE.N said on Wednesday it was withdrawing an application for European approval to use the antibiotic Tygacil for community-acquired pneumonia (CAP).

The company said in a statement that the Committee for Medicinal Products for Human Use found that pivotal clinical trials did not include enough severely ill CAP patients to eliminate concerns about the effectiveness of this drug on such patients.

Tygacil is approved in Europe to treat complicated intra-abdominal infections and complicated skin and soft tissue infections in adults.

Wyeth submitted a similar pneumonia application to the U.S. Food and Drug Administration in October 2007, and it expects a final FDA decision in the second quarter of this year.

Wyeth said in its statement that it believed data submitted to the FDA and other regulatory authorities showed the safety and efficacy of Tygacil for CAP.

The company said Tygacil has been approved for use in CAP patients in the Philippines and Thailand.

Regulatory applications are pending in Australia, Brazil, Canada, Switzerland and India. (Reporting by Deena Beasley, Editing by Toni Reinhold)