Wyeth withdraws EU Tygacil application

Wyeth Pharmaceuticals, a division of Wyeth, has withdrawn its application for an extension to the existing European marketing authorisation for Tygacil (tigecycline).

Tygacil is currently approved in the EU as a treatment for complicated skin and soft tissue infections and intra-abdominal infections.

Wyeth had been hoping to expand the approved indication of the drug to include the treatment of community-acquired pneumonia.

It reports that it has withdrawn this application following the assessment by the Committee for Medicinal Products for Human Use (CHMP) that the pivotal clinical trials for this indication did not contain a sufficient number of severely-ill patients with the condition to alleviate efficacy concerns.

Gary L 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.”

He added that the filing for the drug as a treatment for community-acquired pneumonia was accepted by the US Food and Drug Administration and other regulatory bodies worldwide.

Tygacil was first launched in the UK in July 2007, being the first in a class of antibiotics known as glycylcyclines.