FDA grants fast-track status for anthrax drug

Aug 27, 2003 (CIDRAP News) – A Maryland company says it has received "fast track product" designation from the Food and Drug Administration (FDA) for ABthrax, a drug designed to help prevent and treat anthrax. The FDA grants fast-track status to speed the review process for products that address an "unmet medical need."

Human Genome Sciences, Inc., announced in a press release that ABthrax has been shown "to be effective in protecting against anthrax in multiple experimental models in animals." Rabbits and monkeys exposed to inhalational anthrax had improved survival after receiving one dose of ABthrax. The findings will be presented in September at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Chicago, a company spokesperson, who requested anonymity, told CIDRAP News.

"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," Craig A. Rosen, PhD, president of research and development at Human Genome Sciences, said in the press release.

ABthrax acts against the toxins produced by anthrax rather than the bacteria itself, according to the company. The drug is described as a human monoclonal antibody to Bacillus anthracis protective antigen. It is complementary to the vaccine and antibiotics currently used, the company spokesperson said. ABthrax may be superior to the current vaccine, which requires six shots over 18 months, because it provides full protection sooner, according to the spokesperson. ABthrax could be given to a person who has received some but not all doses of the vaccine and who is needed in an anthrax clean-up or containment effort. It is too soon to tell whether ABthrax could be used instead of the vaccine or antibiotics, according to the spokesperson.

The first phase of human trials of ABthrax is under way and is expected to last several months, according to the spokesperson. In the press release, the Phase 1 trial is described as a "placebo-controlled, dose-escalation clinical trial . . . to evaluate the safety, tolerability and pharmacokinetics of ABthrax." After the trial results are shared with the FDA, the company and FDA will determine if a larger clinical trial should begin, according to the company.

The government is the most likely customer for ABthrax, according to the spokesperson. If the government elected to purchase it for the National Pharmaceutical Stockpile, Human Genome Sciences could manufacture it by late 2004, the spokesperson said.

See also:

FDA information on fast-track designation

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