Wyeth gets positive opinion on antibiotic Tygacil from EU

Tygacil, an antibiotic produced by Wyeth Pharmaceuticals, has received a positive opinion from the European Medicines Agency (EMEA).

Part of the glyclycyclines group of antibiotics, the drug has been indicated for use against complicated skin and intra-abdominal infections including those caused by escherichia coli, streptococcus anginosus, and MRSA.

The recommendation paves the way for the drug to be approved by the European Commission and in the countries of Iceland, Norway and Liechtenstein. Final approval is expected in the second quarter of 2006.

Dr Joesph Camardo, senior vice president of global medical affairs at Wyeth, said: “Life-threatening infections are a growing concern globally. Bacterial infections are becoming more difficult to treat. Tygacil will provide physicians with an important option for patients.”

However, the drug carries a number of side effects. Many patients who took the antibiotic during clinical trials experienced nausea and vomiting, while Wyeth warns that the drug could cause “fetal harm” if given to pregnant women.

The safety of Tygacil among individuals under 18 and lactating women has also not been tested, Wyeth said.

Tygacil has already received approval from the US Food and Drug Administration (FDA). It is being used in 1,450 US hospitals.

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