Rockville-based Emergent BioSolutions Inc. hopes to proceed with human clinical trials for its anthrax treatment vaccine this year, pending a U.S. Food & Drug Administration review.
The company announced Tuesday it has submitted an Investigational New Drug application for its Anthrax Immune Globulin vaccine. The FDA has 30 days to review the application before the company can initiate a clinical trial, which it would conduct with 105 volunteers.
The drug targets patients who present symptoms of anthrax disease. Emergent BioSolutions is conducting the trial with the help of funding from the National Institute of Allergy and Infectious Diseases.
The trial will take around a year to complete, and is the last step before the FDA can grant marketing approval of the drug, according to a March 21 press release from Emergent BioSolutions.
