FDA aids Advanced Life Sciences Holdings in approval assessment for anthrax drug

The U.S. Food and Drug Administration has given guidance to Advanced Life Sciences Holdings, Inc., on the clinical program required to assess the approvability of Restanza, which has been developed to fight anthrax, plague and tularemia, among others.

Officials from the GFA's Anti-Infectives Division met with Advanced Life Sciences earlier this week to provide clarity on the registration pathway for Restanza.

The meeting follows a December 9 FDA Anti-Infective Drugs Advisory Committee meeting to discus clinical trial design issues for the drug's community acquired bacterial pneumonia relative to a March 2009 FDA CABP guidance document.

The FDA had advised Advanced Life Scineces in the earlier meeting to establish a special protocol assessment using a superiority clinical trial, which is meant to compare Restanza to a marketed macrolide antibiotic in two clinical trials.

Advanced Life Sciences, in light of the FDA's guidance, has begun working with the FDA to finalize a special protocol assessment using a superiority design for the outpatient CABP indication.

"We are pleased that the Agency provided clear guidance regarding our registration pathway for Restanza in the CABP and biodefense indications," Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life sciences, said. "Using clinical response in the MRSP population as the primary endpoint provides the most scientifically meaningful approach to demonstrate a clinical efficacy advantage against resistant strains of Streptococcus pneumoniae.

"Based on the data we have accumulated in our extensive pre-clinical and clinical program to date, coupled with a thorough review of published literature on the clinical relevance of macrolide resistance, we believe that Restanza can show a superior efficacy advantage in patients who are resistant to marketed macrolide drugs. With reported macrolide resistance rates as high as 40 percent in the U.S., there is a pressing medical need for new drugs to treat CABP. Our goal is to finalize the SPA by the end of the third quarter of this year."