Elusys Therapeutics Received FDA Approval for Anthim (Oblitoxaximab) Injection against Inhalational Anthrax
Anthim is a monoclonal antibody anthrax antitoxin prescribed in combination with certain antibacterial drugs for the treatment of inhalational anthrax caused by bacillus anthracis in adult and pediatric patients. It is highly effective and thus beneficial as a prophylaxis but only to the person having no hypersensitivity and anaphylaxis complications with anthim.
Inhalational anthrax is the most lethal form of anthrax. The cases observed for the same are quite infrequent in the population but mortality rate for the infection is high. This is caused due to aerosolized spores of anthrax spores, that enter lungs through the air passageway. These spores develop into bacteria that divide inside the lungs, and release toxins that cause infection.
Anthim binds to the protective antigen (PA) component of anthrax toxin. Entry of anthrax toxin into susceptible cells shunned by the anthim’s toxin neutralizing activity, avoiding further proliferation of the toxin throughout the body. It also prevents ensuing tissue damage that leads to death. Anthim is supplied as single-dose vials for intravenous (IV) infusion.
“As preparedness is a cornerstone of any bioterrorism response, we are pleased to see continued efforts to develop treatments for anthrax” said Edward Cox, M.D, M.P.H, director of the office of antimicrobial product’s FDA’s center for drug evaluation and research.
The efficacy of anthim was based on the two studies done on animal models of inhalational anthrax for safety profiling and pharmakokinetics study. No study was performed on pediatric population due to feasibility and ethical issues. Therefore, pediatric patient’s dosage was determined using a population PK approach.
Anthim was developed by Elusys Therapeutics, Inc. of Pine Brook, New Jersey, in conjunction with the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority.
Featured image credit: Anthrax © MrDrive (Stock Photo ID: 2584592)