Emergent BioSolutions, Inc.'s inhalational anthrax treatment receives Fast Track status

Emergent BioSolutions, Inc., announced on October 1 that the U.S. Food and Drug Administration has granted Fast Track Designation for its anthrax monoclonal antibody development program investigating AVP-21D9 for the treatment of inhalation anthrax.

AVP-21D9 recently began a Phase I clinical trial, which involves 50 volunteers. It is a fully human monoclonal antibody candidate that is billed as a parenteral post-exposure therapeutic.

“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,” Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions, Inc., said.

The FDA’s Fast Track Designation is intended to provide for the expedited review of therapeutics that demonstrate a potential to solve currently unmet medical needs. Under Fast Track Designation guidelines, Emergent BioSolutions, Inc., can receive expedited regulatory treatment that includes frequent meetings and written correspondence with FDA officials, priority review of its Biological License Applications and the ability to submit its BLA on a rolling basis.

“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,” Abdun-Nabi said.