GlaxoSmithKline’s (NYSE:GSK) raxibacumab injection to treat inhalational anthrax has received approval by the U.S. Food and Drug Administration under the agency’s Animal Efficacy Rule, which allows data from animal studies to supply evidence for new drug applications when it is not feasible or ethical to conduct trials in humans.
According to a statement issued by the FDA, raxibacumab neutralizes toxins produced by the bacterium Bacillus anthracis, which can cause “massive and irreversible tissue injury and death.” As a monoclonal antibody, the drug is a protein that mimics antibodies produced by the human body that identify and eliminate bacteria and viruses.
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Because the agency determined that raxibacumab had the potential to meet an unmet medical need, the drug was given a fast track designation, which accelerates the approval of investigational new drugs, a priority review, and an orphan product designation that is granted to drugs that treat rare diseases or conditions that affect fewer than 200,000 people in the United States. Without the designation, many drug companies would not find it profitable to pursue treatments for drugs with such small potential markets.
But raxibacumab is more than just a drug to treat an unusual ailment. “In addition to antibiotics, raxibacumab will be a useful treatment to have available should an anthrax bioterrorism event occur,” said Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “Although antibiotics are approved to prevent and treat anthrax infection, raxibacumab is the first approved agent that acts by neutralizing the toxins produced by B. anthracis.”
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