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USFDA approved Anthim

24-Mar-2016

The United States Food and Drug Administration (USFDA) has approved Anthim (Obiltoxaximab) injection for treatment of inhalation anthrax as a combined therapy with conventional antibiotics. Anthim is indicated when other therapies are not available or not appropriate.

 

Anthim is a monoclonal antibody that specifically binds and neutralizes bacterial toxins produced by Bacillus anthracis. The approval was based on experimental animal and human clinical trial studies.

 

The efficacy of Anthim was demonstrated in placebo-controlled animal studies. Administration of Anthim in addition to antibacterial drugs has resulted in improved survival outcomes, compared to antibiotics monotherapy.

 

Anthim was tested in 320 healthy human subjects, and some of the reported common adverse events were headache, itching, upper respiratory tract infections, cough, hives, edema, headache, bruising, nasal congestion and injection site reactions.

 

Anthim is to be marketed with a Boxed Label Warning about the potential risk of developing anaphylactic reactions, and hence it should be administered by a clinician in clinical care settings.

 

As anthrax infection is a life-threatening infection, Anthim treatment can potentially outweigh the possible risks.

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