Elusys' anthrax treatment approved in US

The US Food and Drug Administration has approved Elusys Therapeutics' Anthim (obiltoxaximab) inhaled anthrax drug.

The FDA announced yesterday that Anthim has been approved to treat inhalational anthrax in combination with appropriate antibacterial drugs.

It is also approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate.

Elusys has been collaborating with the US government authorities to develop the drug, which will be added to a national stockpile to protect citizens and emergency personnel in the event of a biowarfare attack.

Development has been funded by more than $220 million in grants, and New Jersey-based Elusys received its first delivery order, valued at $44.9 million, in October.

Anthim is a monoclonal antibody that binds to the protective antigen component of anthrax toxin. Its toxin neutralising activity prevents entry of anthrax toxin into susceptible cells, avoiding further spread of the toxin throughout the body and the tissue damage that leads to death.

Anthim is supplied as single-dose vials for intravenous infusion. Efficacy data was based on animal studies under the FDA's Animal Rule, which applies when it is not feasible or ethical to conduct efficacy trials in humans. Safety was evaluated in 320 healthy volunteers.

The most frequently reported side effects were headache, itching (pruritus), upper respiratory tract infections, cough, nasal congestion, hives, and bruising, swelling and pain at the infusion site.