FDA Grants Orphan Drug Designation To Advanced Life Sciences’ Restanza

The FDA has granted Orphan Drug Designation to Advanced Life Sciences’ Restanza (cethromycin), its novel, once daily oral antibiotic, for the prophylactic treatment of plague and tularemia.

Advanced Life Sciences is currently conducting pivotal studies of Restanza under FDA’s ‘Animal Rule’ under a contract with the US Department of Defense.

The company has previously reported that Restanza demonstrated significant efficacy in preventing anthrax infection post-exposure as well as in treating inhalation anthrax after symptoms of infection had developed.

The company expects key data to be available and reported from its pivotal animal studies in plague and tularemia by the end of 2009.

The company said that if these studies continue to confirm the product profile of Restanza as a potent broad spectrum medical countermeasure for biodefense, Advanced Life Sciences plans to meet with the FDA to finalise the biodefense regulatory plan for Restanza. The company plans to submit an NDA amendment seeking marketing approval for the biodefense indications of anthrax, tularemia, and plague in the first part of 2010.

Michael Flavin, chairman and CEO of Advanced Life Sciences, said: “We believe that Restanza is a major advance in biodefense preparedness against lethal pathogens, given its novel mechanism of action, demonstrated broad spectrum of activity against multiple bioterror agents and favorable safety profile.

“We look forward to continuing to work with the US government on the development of this promising new antibiotic and to meeting with the FDA to determine the regulatory pathway to approval for Restanza in the biodefense indications.”