In a latest press release the United States Food and Drug Administration has approved raxibacumab injection to treat the patients for the deadly ‘inhalational anthrax’. Reports suggest that around 1 million people somehow get infected with this disease every year in the United States. Inhalational Anthrax is a form of the infectious disease caused by breathing in the spores of the bacterium Bacillus anthrax.

According to various reports the move is going to be a crucial one in the drug and pharmaceutical sector as it will offer an alternative treatment for people who are suffering from this deadly disease. The FDA has also given approval to Raxibacumab injection to prevent inhalational anthrax when alternative therapies are not available or not appropriate.

The notification for the approval was issued on December 14, 2012 which was overwhelmingly welcomed by medical professionals and industry experts as there was an acute need for such alternative treatment.

The approved injection Raxibacumab is a monoclonal antibody that neutralizes toxins produced by B. anthracis that can cause massive and irreversible tissue injury and death. Monoclononal antibodies have emerged as an effective treatment for various diseases that are life-threatening and can cause major loss to human life. Reports from various sources have suggested that Anthrax is a potential biological terrorism threat because the spores are resistant to destruction and can be easily spread by release in the air.

It is important to underline here that the raxibacumab injection is enjoying the status of “Orphan Drug” a status given by FDA only to those drugs that treat rare diseases. The approval for the injection was given on a fast track designation basis. The drug demonstrated the potential to fill an unmet medical need, has the potential to provide safe and effective treatment where no satisfactory alternative therapy exists, and is intended to treat a rare disease, respectively.

According to the reports from the federal agency Food and Drug Administration Raxibacumab is one of the first monoclonal antibodies that were approved under the FDA’s Animal Efficacy Rule, which allows efficacy findings from adequate and well-controlled animal studies to support FDA approval when it is not possible to conduct adequate efficacy trials in humans.

What is Raxibacumab?

Raxibacumab is a human monoclonal antibody intended for the prophylaxis and treatment of inhaled anthrax. Its efficacy has been proved in rabbits and monkeys. As of January 2011, the drug had reached stage three clinical testing in humans.