FDA says Human Genome anthrax drug works in animals, questions remain about human use

FDA reviews Human Genome’s anthrax medication

WASHINGTON — The Food and Drug Administration says Human Genome Sciences’ ABthrax successfully treated animals exposed to anthrax, though the agency has questions about its use in humans.

The Rockville, Md.-based company has asked the FDA to approve the inhalable drug to treat the anthrax toxin once it has entered the bloodstream. The U.S. government has already ordered more than 60,000 doses for its national emergency stockpile.

FDA reviewers say the drug appeared effective when used with antibiotics in rabbits and monkeys. But the agency notes such animal studies do not always predict success in humans.

On Tuesday the agency will ask an outside panel to weigh in on the results. The FDA is not required to follow the group’s advice, though it often does.