Anthim Approval History
Anthim (obiltoxaximab) is a monoclonal antibody (mAb) anthrax antitoxin for the treatment and prevention of inhalational anthrax.
Inhalation anthrax is considered to be the most deadly form of anthrax. It is caused by breathing in spores of the anthrax bacteria Bacillus anthracis, which when inhaled, replicate and produce a potentially lethal toxin. Anthim works by preventing entry of the toxin into susceptible cells, reducing spread, and limiting tissue damage.
Anthim was approved under the FDA's Animal Rule, which allows efficacy findings from animal studies when it is not feasible or ethical to conduct efficacy trials in humans.
Anthim is indicated for the treatment of anthrax in combination with appropriate antibacterial drugs (levofloxacin, ciprofloxacin and doxycycline), and is administered as a single-dose intravenous infusion. Hypersensitivity reactions, including anaphylaxis, have been reported during infusion, and premedication with diphenhydramine is recommended. The most common side effects reported in healthy volunteers who participated in the safety studies were headache, itching, upper respiratory tract infections, cough, nasal congestion, urticaria, pain in extremities, and bruising, swelling and pain at the infusion site.
Development History and FDA Approval Process for Anthim
|Mar 21, 2016||FDA Approves Anthim (obiltoxaximab) for Inhalation Anthrax|
|Jun 1, 2015||FDA Accepts Biologics License Application for Anthim (Obiltoxaximab)|
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