Regulatory Decision Summary for Anthim
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
This submission was accepted as an extraordinary use new drug submission (EUNDS), under the Health Canada EUND pathway. It is not ethical to intentionally expose humans to a deadly bacterium and not feasible to conduct well-controlled clinical trials due to the rare occurrence and sporadic nature of natural exposure to anthrax, and an emergency setting such as an outbreak requires rapid intervention at locations that cannot be predetermined. Therefore, the effectiveness of Anthim is based on efficacy studies demonstrating a survival benefit in animal studies.
The purpose of this extraordinary use new drug submission is to seek marketing authorization of Anthim. The approved indications are:
- Anthim (obiltoxaximab for injection) is indicated in adult and pediatric patients for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs.
- Anthim is indicated for post-exposure prophylaxis of inhalational anthrax due to B. anthracis when alternative therapies are not available or not appropriate.
Why was the decision issued?
The efficacy of Anthim was established in studies in animal models with inhalational anthrax disease. The studies demonstrated that the Anthim with a dose level of 16 mg/kg can provide protection, in terms of survival rates, to the animals with inhalational anthrax disease. In addition, Anthim administered in combination with antibiotics (levofloxacin, ciprofloxacin, doxycycline) resulted in higher survival outcomes than antibiotics alone in multiple studies where Anthim and antibiotics were given at various doses and treatment times.
The safety of Anthim was evaluated in healthy adult subjects in three clinical trials with a dose level of 16 mg/kg. The main safety concern identified was the hypersensitivity reactions, which include rash, urticaria, pruritus, and anaphylactic reaction.
The benefit of Anthim for treatment of inhalational anthrax, a potentially fatal infection, outweighs the identified risks. Identified risks and uncertainties are described in the Product Monograph.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.