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Advanced Life Sciences will begin new studies for Restanza

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Advanced Life Sciences will conduct a new set of pivotal trials for its antibiotic Restanza, this time with a superiority design. The sponsor announced March 11 that it had met with FDA and reached an agreement for new clinical trials to be conducted under a special protocol assessment (1"The Pink Sheet" DAILY, March 11, 2010). The new pathway will compare Restanza to a marketed macrolide antibiotic, using clinical cure rate in a macrolide-resistant Streptococcus pneumoniae population as the primary endpoint. Restanza's original development occurred in parallel with FDA's refinement of its standards for community-acquired bacterial pneumonia drugs. The agency issued a draft guidance on non-inferiority margins for CABP trials in March 2009, and Advanced Life Sciences' September 2008 application was evaluated based on those standards at a June 2009 advisory committee, where the panel agreed with FDA's conclusion that the efficacy evidence from the non-inferiority trials was insufficient (2"The Pink Sheet," June 8, 2009)

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