HGS receives fast track approval for Anthrax antidote
US-based Human Genome Sciences (HGS) has received a fast track product designation from the FDA for ABthrax, a novel drug for the prevention and treatment of anthrax infections.
US-based Human Genome Sciences (HGS) has received a fast track product designation from the FDA for ABthrax, a novel drug for the prevention and treatment of anthrax infections.
For new drugs to be designated a fast track product, the condition it is designed to treat must be serious or life-threatening, and must represent an unmet medical need. The FDA also must determine that the drug has the potential to address the unmet medical need and that the development program is designed to evaluate this potential.
HGS has initiated a Phase I placebo-controlled, dose-escalation clinical trial of ABthrax in healthy adult volunteers to evaluate the safety, tolerability and pharmacokinetics of ABthrax. The trial will evaluate different dose levels of intramuscularly administered ABthrax and intravenously administered ABthrax. The ABthrax used for preclinical and clinical studies is produced in the Company's manufacturing facilities in Rockville, Maryland.
Dr Sally D Bolmer said, 'We are pleased that the FDA has decided to grant fast track status to ABthrax for use in preventing and treating anthrax infections. We look forward to the opportunity for close cooperation with the FDA as we continue the development of this novel antibody drug.'
Dr Craig A Rosen, president, r&d, said: 'We believe that ABthrax has the potential to provide significant protection against anthrax infections when given prophylactically, and may lessen the natural progression of anthrax infection and increase survival if given as a post-exposure treatment. ABthrax also may prevent and treat infections by antibiotic-resistant strains of anthrax.'
What is ABthrax?
ABthrax is a human monoclonal antibody to Bacillus anthracis protective antigen that was discovered and developed by Human Genome Sciences. ABthrax has been shown to be effective in protecting against anthrax in multiple experimental models in animals. A single dose of ABthrax increases survival significantly in both rabbit and nonhuman primate models of inhalational anthrax.