March 13, 2006

A European Union (EU) pharmaceutical advisory committee has recommended approval of Wyeth Pharmaceuticals' first-in-class antibiotic Tygacil (tigecycline), the firm announced.

The "positive opinion" by the EU's Committee for Medicinal Products for Human Use is the final step before final EU approval, which is expected in the second quarter, Wyeth said recently. Tygacil received FDA approval on June 15, 2005. The drug is indicated for the treatment of complicated skin and soft-tissue infections and complicated intra-abdominal infections.

The introduction of Tygacil to the European market will come at a time when the need for new antibiotic options to combat serious infections is increasing, according to a top Wyeth official. "Life-threatening infections are a growing concern globally," said Joseph Camardo, senior vice president of Global Medical Affairs at Wyeth. "Bacterial infections are becoming more difficult to treat. Tygacil will provide physicians with an important option for patients."

The drug also has received approval in six other countries: Brazil, Colombia, Mexico, Peru, Argentina and Ecuador.