FDA Designates Anthrax Treatment Candidate as Orphan Drug

Anthrax spores (U.S. Food and Drug Administration)

Emergent BioSolutions Inc., a biotechnology company in Rockville, Maryland, says the U.S. Food and Drug Administration (FDA) has designated as an orphan drug its human anthrax monoclonal antibody AVP-21D9, in development for the treatment of inhalation anthrax. FDA grants orphan status to drugs and biologics being developed to treat rare conditions, specifically those affecting fewer than 200,000 persons in the U.S.

Inhalational anthrax is the most lethal form of anthrax, and consequently aerosolized anthrax spores are the most likely method to be used in a potential anthrax bioterrorism attack. Once the inhaled anthrax spores germinate, they release several toxic substances, which cause internal bleeding, swelling, and tissue death.

The company says AVP-21D9 is in a randomized, double-blind, placebo-controlled, dose escalation Phase I clinical study involving 50 healthy volunteers designed to evaluate the safety and pharmacokinetics of the product.

According to Emergent BioSolutions, FDA’s orphan drug designation provides a number of incentives for AVP-21D9, including a seven-year period of marketing exclusivity, reduced regulatory fees, certain tax credits, and additional regulatory support for research and development initiatives.

Related: FDA Fast-Tracks Antibody for Inhalational Anthrax Treatment

*     *     *