Anthrax drug maker questions approval process for drug

The delay to Human Genome Sciences' experimental anthrax drug appears inconsistent with published final rules governing the development of new drugs by the FDA, an HGS spokesperson has said.

The Food and Drug Administration said in a letter to HGS that it required more information about HGS' anthrax drug, called raxibacumab. Until that information, which HGS is not identifying, is provided, the FDA will withhold approval.

Sally D. Bolmer, HGS' senior vice president of development and regulatory affairs, has questioned the FDA's request for more information, citing the hurdles involved the development of a drug for which human testing would cross ethical boundaries.

Bolmer said that the FDA's questions appear to contradict the FDA's rules about developing new drugs when human efficacy studies are either not ethical or not feasible.

Raxibacumab, also known as ABthrax, was developed for people who have already been infected with anthrax. Raxibacumab is designed to target anthrax once the toxin has been released into the body through inhalation.

Despite the lack of approval for raxibacumab, the U.S. Strategic National Stockpile has already received 20,000 doses of the drug in April under a federal contract. An additional 45,000 doses of the drug were ordered in July to be delivered over three years.