New Treatment for Inhalation Anthrax Approved

The FDA has granted approval for obiltoxaximab (Anthim/Elusys Therapeutics) to treat inhalation anthrax in combination with antibacterial drugs.

Anthim is also approved to prevent inhalational anthrax when alternative therapies are unavailable.

When inhaled, the anthrax bacteria replicate in the body and produce toxins, which can cause toxins that can trigger tissue injury and death.

Anthim was approved under the FDA’s Animal Rule, which allows the implementation of well-controlled animal studies to support the investigation of efficacy findings, when it is not pragmatic or ethical to conduct trials on humans.

The primary endpoint of Anthim’s efficacy study was based on survival at the end of the studies. Results indicated that compared to the placebo group, more animals treated with Anthim actually survived. Furthermore, when patients were administered Anthim with antibacterial drugs, the survival outcomes were reported to be higher.

Anthim’s safety was tested in 320 healthy human volunteers.

The most commonly reported adverse events were headache, itching, upper respiratory tract infections, cough, nasal congestion, hives, bruising, swelling, and pain at the infusion site.

As Anthim does had a boxed warning regarding allergic reactions, officials urge healthcare providers to administer the drug in settings where the patents can easily be monitored and treated for anaphylaxis.

Edward Cox, MD, MPH, director of the Office of Antimicrobial Products, FDA’s Center for Drug Evaluation and Research, said in a news release, “As preparedness is a cornerstone of any bioterrorism response, we are pleased to see continued efforts to develop treatments for anthrax.”