FDA Releases a New Drug Called Raxibacumab, New Treatment for Inhalational Anthrax

With the current drugs not adequate enough to treat inhalational anthrax, the FDA has released a
new drug called ‘raxibacumab’ that will counter the effects of Bacillus anthracis. Explaining the new approach to treating this rare disease, Edward Cox, director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research, said, “In addition to antibiotics, raxibacumab will be a useful treatment to have available should an anthrax bioterrorism event occur.

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.” By nature, Raxibacumab is a monoclonal antibody that can neutralize toxins which, in turn, can cause tissue damage and death. What is intriguing about this decision is that the drug has been approved under the Animal Efficacy Rule since it has only been tested on animals under controlled conditions due to not being able to find human subjects with this rare disease.

However, by virtue of being a monoclonal antibody, which resembles a human antibody, its approval has come after tests on monkey and three tests on rabbits who all survived after being exposed to aerosolized B. Anthracis spores and treated with varying doses of  he drug as opposed to those who didn’t when treated with a placebo. The drug, which was developed by GlaxoSmithKline PLC’s Human Genome Sciences, was also tested on 326 human volunteers in good health. The side effects that were found were itching pain,
drowsiness and rash.