FDA approves Anthim for treatment of inhalational anthrax

The U.S. Food and Drug Administration (FDA) announced this week the approval of Anthim (oblitoxaximab) injection for the treatment of inhalational anthrax to be used in combination with antibacterial drugs.

Anthim has also been approved for the prevention of inhalational anthrax when alternate therapies are not accessible or are not suitable.

Inhalational anthrax is a rare illness that can be contracted by being exposed to infected animals or contaminated animal products. It can also occur as a result of the deliberate release of anthrax spores.
  
Breathing in Bacillus anthracis spores is the cause of the disease. When these spores are inhaled, the anthrax bacteria replicates and produces toxins that can cause considerable and permanent tissue injury or even death. Anthrax is a bioterrorism threat due to the indestructability of the spores and because it can be spread by release into the air.

Anthim is a monoclonal antibody that was designed to neutralize the toxins that are produced by B. anthracis. The medication has been approved in accordance with the FDA’s Animal Rule. The Animal Rule allows for well-controlled animal studies that support FDA approval when human trials cannot be conducted feasibly or ethically.