Advanced Life Sciences will begin new studies for Restanza
This article was originally published in Pharmaceutical Approvals Monthly
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 The agency issued a draft guidance on non-inferiority margins for CABP trials in March 2009, and Advanced Life Sciences' September 2008 application was evaluated based on those standards at a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)
You may also be interested in...
Company sees options in recommendations from FDA advisory committees for community-acquired bacterial pneumonia and for use of animal efficacy rule for biodefense indications.
Advanced Life Sciences has not given up on developing its investigational drug Restanza (cethromycin) for community acquired pneumonia, despite a June 2 recommendation by the FDA Anti-infective Drugs Advisory Committee that the drug should not be approved for CAP due to lack of efficacy
In this week's podcast version of Five Must-Know Things: planned US drug pricing legislation in focus; solid quarter but no Seagen announcement for Merck & Co; AbbVie’s Gonzalez sounds alarm over US pricing legislation; Alnylam ready to expand in amyloidosis; and Boehringer Ingelheim on global Jardiance strategy.