Emergent BioSolutions Inc announced that its anthrax monoclonal antibody development programme investigating AVP-21D9 for the treatment of inhalational anthrax has been granted Fast Track Designation by the US Food and Drug Administration (FDA). Emergent recently commenced a phase-I clinical trial for AVP-21D9, which is a fully human monoclonal antibody product candidate being developed as a parenteral post-exposure therapeutic to treat symptoms of inhalational anthrax disease.
"Emergent is pleased to receive FDA Fast Track Designation, which is designed to facilitate the development and review of new drugs and biologics, and could allow the shortest time to approval of our anthrax monoclonal antibody therapeutic," said Daniel J Abdun-Nabi, president and chief operating officer of Emergent BioSolutions. "We look forward to continuing to work with the FDA to fill this significant unmet medical need and to address the acknowledged threat of inhalational anthrax as a biological weapon."
The FDA's Fast Track Development Program provides for expedited regulatory review of drugs and biologics that treat serious or life threatening diseases and demonstrate the potential to address unmet medical needs. Under the Fast Track Designation, Emergent is now eligible to receive expedited regulatory treatment, including frequent FDA meetings and written correspondence, receive priority review of its Biological License Applications (BLA) for the product, and submit its BLA on a rolling basis, which allows the FDA to review sections of the BLA in advance of receiving the complete submission.
Emergent's phase-I clinical trial, which involves 50 healthy volunteers, is a randomized, double-blind, placebo-controlled, dose escalation study designed to evaluate the safety and pharmacokinetics of the monoclonal antibody candidate.
Emergent BioSolutions is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and antibody therapies that assist the body's immune system to prevent or treat disease.