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Blow for Wyeth Tygacil application

Wyeth Europa has withdrawn its application to approve Tygacil for extended uses in the European market.

Wyeth Europa has withdrawn its application to approve Tygacil for extended uses in the European market.

Tygacil (tigecycline) is currently approved for the treatment of complicated skin, soft tissue and intra-abdominal infections. Wyeth had hoped that the drug would be given further indication to treat patients with community-acquired pneumonia (CAP).

The Committee for Medicinal Products for Human use (CHMP) said not enough critically ill patients were included in pivotal trials to prove the drugs efficacy and safety, leaving reviewers unable to render an informed decision. Subsequently, Wyeth withdrew the application for extended marketing authorisation from the European Medicines Agency (EMEA).

Dr Gary Stiles, executive vice-president and chief medical officer of 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."

Wyeth filed a supplemental new drug application (ND) to the US Food and Drug Administration (FDA) in October 2007 for the same treatment indication. An FDA decision is expected in the second quarter of 2008 and outcomes of regulatory reviews are pending in Australia, Brazil, Canada, Switzerland and India.

"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," Stiles concluded.

At present, Tygacil is approved for therapeutic use patients with CAP in the Philippines and Thailand.

25th April 2008

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