The US Food and Drug Administration (FDA) has given its approval to a drug meant to treat patients infected by inhalational anthrax.
The FDA has given green signal to Anthrasil which can be used in combination with appropriate antibacterial drugs. The approval gives a $7 million payment to Emergent BioSolutions under a Biomedical Advanced Research and Development Authority contract.
Anthrasil can be used against inhalation anthrax, which can occur after a person is exposed to infected animals or contaminated animal products, or as the result of the intentional release of anthrax spores in a bioterrorism attack. This results into the inhalation of Bacillus anthracis. After the bacterium enters the body, it replicates and produces toxins, causing massive, irreversible injury to tissues. The anthrax bacteria can also cause death.
The drug’s approval by the FDA increases the United State’s efforts at preparing for the possibility of an anthrax attack. It also increases the number of drugs that are part of the U.S. Strategic National Stockpile. Anthrasil has been accessible prior to the FDA’s approval but its use would warrant an emergency use authorization from the agency.
Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said, “Today’s approval provides an important additional treatment to other FDA-approved therapies for inhalational anthrax, a life-threatening disease. This product will be stored in U.S. Strategic National Stockpile to facilitate its availability in response to an anthrax emergency.”
Emergent BioSolutions stated that Anthrasil is produced from purified human immune globulin G that contains polyclonal antibodies targeting anthrax toxins created by Bacillus anthracis. The drug is made using plasma from healthy individuals, which have been previously immunized with BioThrax. BioThrax is Emergent BioSolutions’ anthrax vaccine. BioThrax is also the only vaccine licensed by the FDA to prevent anthrax disease.
Anthrasil was safely tested on 74 volunteers, some of whom reported side-effects like swelling, nausea, back pain, headaches and pain on the infusion site.