Anthrax is an infection caused by a spore-forming bacteria called bacillus anthracis, often found in farm animals like cows and sheep.
According to U.S. Center for Disease Control and Prevention (CDC), most infections occur when the bacteria enters the skin when exposed to infected farm animals; however, the infection can also be caused in the intestine by eating contaminated meat.
An advisory panel from the FDA is likely to give its final recommendation on Oct. 27 where the drug’s potential benefits and risks will be weighed and it will be decided whether to approve drug treatment or not.
Animal studies not sufficient to prove Abthrax’s efficacy
To test the effectiveness of Abthrax, infected animals including monkeys and rabbits were treated with the drug in combination of some antibiotics capable of treating anthrax.
It was found that single dose of Abthrax combined with the antibiotics showed similar efficacy when compared with single dose of the antibiotics, which raised doubts about the efficiency of the drug.
"When given in combination with antimicrobials, the efficacy of the combination was high, but the efficacy of antimicrobials alone was also high, raising the question of whether the animal model adequately reflects the findings from patients with inhalational anthrax," states the FDA report.
Though the drug successfully treated the infected animals, the FDA report reasons that animal studies may not be sufficient to prove the drug’s effectiveness in warding off the illness among humans.
While Abthrax has yet not received any regulatory approval, the U.S. government has already ordered more than 60000 doses of the drug from the Strategic National Stockpile.
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