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.S. Food and Drug Administrationrotecting and Promoting
Your Health
FDA News Release
FDA approves new treatment forinhalation anthrax
For Immediate Release
March 21, 2016
Release
On Friday, March 18, the U.S. Food and Drug Administration
approved Anthim (obiltoxaximab) injection t
treat inhalational anthrax in combination with appropriate
antibacterial drugs. Anthim is also approved to
prevent inhalational anthrax when alternative therapies are not
available or not appropriate.
Inhalational anthrax is a rare disease that can occur after
exposure to infected animals or contaminated
animal products, or as a result of an intentional release of
anthrax spores. It is caused by breathing in the
spores of the bacterium Bacillus anthracis. When inhaled, the
anthrax bacteria replicate in the body and
produce toxins that can cause massive and irreversible tissue
injury and death. Anthrax is a potential
bioterrorism threat because the spores are resistant to
destruction and can be spread by release in the a
“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
Products in FDA’s Center for Drug Evaluation and Research.
Anthim is a monoclonal antibody that neutralizes toxins produced
by B. anthracis. Anthim was approved
under the FDA’s Animal Rule, which allows efficacy findings from
adequate and well-controlled animal
studies to support FDA approval when it is not feasible or
ethical to conduct efficacy trials in humans.
Anthim’s effectiveness for treatment and prophylaxis of
inhalational anthrax was demonstrated in studies
conducted in animals based on survival at the end of the
studies. More animals treated with Anthim livedcompared to animals
treated with placebo. Anthim administered in combination with
antibacterial drugs
resulted in higher survival outcomes than antibacterial therapy
alone.
The safety of Anthim was evaluated in 320 healthy human
volunteers. The most frequently reported side
effects were headache, itching (pruritus), upper respiratory
tract infections, cough, nasal congestion, hive
and bruising, swelling and pain at the infusion site.
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Anthim carries a Boxed Warning alerting patients and health care
providers that the drug can cause
allergic reactions (hypersensitivity), including a severe
reaction called anaphylaxis. Anthim should be
administered in settings where patients can be monitored and
treated for anaphylaxis. However, given th
anthrax is a very serious and often deadly condition, the
benefit of Anthim for treating anthrax is expected
to outweigh this risk.
Anthim was developed by Elusys Therapeutics, Inc. of Pine Brook,
New Jersey, in conjunction with theU.S. Department of Health and
Human Services’ Biomedical Advanced Research and Development
Authority.
The FDA, an agency within the U.S. Department of Health and
Human Services, protects the public healt
by assuring the safety, effectiveness, and security of human and
veterinary drugs, vaccines and other
biological products for human use, and medical devices. The
agency also is responsible for the safety an
security of our nation’s food supply, cosmetics, dietary
supplements, products that give off electronic
radiation, and for regulating tobacco products.
###
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Lyndsay Meyer (mailto:[email protected])
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