Emergent BioSolutions, Inc. announced on November 4 that AVP-21D9, its fully human monoclonal antibody for the treatment of inhalation anthrax, has been granted Orphan Drug Designation by the U.S. Food and Drug Administration.
Orphan Drug Designation is given to biologics and medicines that are being developed in order to treat conditions that are rare, generally those that affect fewer than 200,000 people in the United States. It grants the companies that develop such drugs the right to sell them without competition for seven years. It also grants certain clinical trial tax incentives, reduced regulatory fees and additional regulatory support for research and development initiatives.
"Receiving FDA Orphan Drug Designation for our investigational monoclonal antibody underscores the unmet medical need in treating inhalation anthrax disease," Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions, Inc., said. "Emergent is committed to advancing product candidates that could help address that need. We also fully support the U.S. government's preparedness efforts against the threat of anthrax as a biological weapon through continuing to manufacture and deliver doses of BioThrax, the only vaccine licensed by the FDA for the prevention of anthrax infection, into the strategic national stockpile."
AVP-21D9 is currently undergoing a randomized, double-blind, placebo controlled, dose escalation Phase I clinical study using 50 healthy volunteers. The trial is designed to evaluate the safety and pharmacokinetics of the drug candidate.