The US Food and Drug Administration (FDA) said it had cancelled review of telavancin, made by Theravance, Inc., in order to get more time to further evaluate study site monitoring and study conduct to ensure data integrity in the ATLAS phase III programme for the treatment of complicated skin and skin structure infections (cSSSI).
The FDA indicated that, due to study monitoring issues at a single study site managed by the primary contract research organization for the ATLAS programme, the agency intends to evaluate additional sites, and that additional questions could arise after further evaluation.
"We were disappointed when we learned of the Advisory Committee meeting cancellation," said Rick E Winningham, chief executive officer. "Telavancin was studied in a large, thoughtfully designed, and rigorously conducted complicated skin and skin structure infection clinical development program. On January 30, 2008, the FDA requested the removal of data generated by one of our study sites from the AIDAC briefing documents. The removal of these data had no material impact on the overall efficacy and safety results or conclusions of the study previously reported, and we believed the site issue had been adequately addressed by the data removal. We are committed to working with the FDA to resolve outstanding issues related to the ATLAS programme."
Telavancin's review was planned on February 27, 2008 by the Anti-Infective Drugs Advisory Committee (AIDAC).