The US Food and Drug Administration (FDA) has granted orphan drug designation to Restanza, from Advanced Life Sciences, a novel antibiotic currently under research by the US Defence department as a potential defence against lethal pathogens such as anthrax and the plague.
Advanced Life Sciences is currently conducting studies of Restanza as a bioterror countermeasure agent under a contract with the US Department of Defence.
Restanza (cethromycin) is novel, once-daily oral antibiotic, for the prophylactic treatment of plague and tularaemia, both of which are classified as category A bioterrorism agents by the US Center for Disease Control.
The company has also reported that the drug has demonstrated significant success in preventing anthrax infection and symptoms post-exposure.
The company is presently conducting animal studies on plague and tularaemia under the FDA’s ‘animal rule’ by the end of 2009.
If these studies continue to confirm the usefulness of Restanza as a potent medical biodefence, Advanced Life Sciences will meet with the FDA early next year to finalise a biodefence regulatory plan and to seek marketing approval.
Advanced Life Sciences chairman and chief executive officer Michael T Flavin said that Restanza could be a major breakthrough in biodefence preparedness against lethal pathogens.
“Pathogens such as anthrax, plague and tularemia represent extreme public health threats of potentially epidemic proportion as they are highly infectious and fatal diseases particularly if aerosolised,” Flavin said.
“Restanza is a major advance, given its novel mechanism of action, demonstrated broad spectrum of activity against multiple bioterror agents and favourable safety profile.”
The FDA’s Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders.