Under a contract with U.S. Biomedical Advanced Research and Development Authority, the company has delivered 20,000 doses of raxibacumab to the U.S. Strategic National Stockpile for emergency use. Approval of the drug by the U.S. Food and Drug Administration is pending, Bolmer said.
Mingtao Zeng, an assistant professor in the department of microbiology and immunology at the University of Rochester Medical Center, said this study has provided solid data to support raxibacumab as a new candidate drug for biodefense and public health.
"The most encouraging finding is that raxibacumab appeared to be safe and well-tolerated, with reasonably high doses in the phase 1 human clinical trial, which had 333 healthy human volunteers," Zeng said. "I anticipate that raxibacumab can be used as a short-term prophylactic agent for protection against anthrax or as a therapeutic drug in combination with antibiotics for effective treatment of anthrax."
Dr. Gary Nabel, director of the Vaccine Research Center at the U.S. National Institute of Allergy and Infectious Diseases and author of an accompanying journal editorial, said the paper shows that the antibody can block infection in animals and similar levels of the drug can be safely given to people.
"It therefore satisfies the criteria of the animal rule, a regulatory guideline used to approve drugs for diseases that can't be tested for efficacy in humans," Nabel said.
This antibody provides a new tool to control anthrax infection and "if approved, could be stockpiled as a countermeasure against this potential public health threat," he said.
"This paradigm of drug approval for biodefense agents provides a new way to address such threats, though questions remain about how and when to use such drugs and how to incentivize industry to produce th
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