Wyeth Pharmaceuticals' antibiotic Tygacil receives 'positive opinion' in Europe

By Elaine Rigoli

Tampa, Fla., March 2 - Wyeth Pharmaceuticals, a division of Wyeth, announced Thursday that it has received a "positive opinion" recommending approval for the introduction of its first-in-class antibiotic Tygacil (tigecycline) to the European market by the Committee for Medicinal Products for Human Use (CHMP).

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 company news release.

Final E.U. approval is expected in the second quarter of 2006, the release said.

"Life-threatening infections are a growing concern globally," said Joseph Camardo, senior vice president, global medical affairs, in the release.

"Bacterial infections are becoming more difficult to treat. Tygacil will provide physicians with an important option for patients."

The "positive opinion" is the final step before formal approval to market Tygacil in the 25 member states of the European Union, Iceland, Liechtenstein and Norway, the release said.

The CHMP recommendation of Tygacil will now be forwarded to the European Commission for final approval, which is anticipated in the second quarter of 2006.

Tygacil has also received approval in Brazil, Colombia, Mexico, Peru, Argentina and Ecuador.

Specifically in Europe, Tygacil will be indicated for the treatment of complicated skin and soft-tissue infections and complicated intra-abdominal infections.

Tygacil received approval for use in the United States by the Food and Drug Administration on June 15, 2005. Since then, Tygacil has been placed on formulary at more than 1,450 of the largest hospitals in the United States, the release said.

Madison, N.J.-based Wyeth focuses on women's health care, cardiovascular disease, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.

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