FDA Approves Raxibacumab
Food and Drug Administration (FDA) has give approval to Raxibacumab, a drug by GlaxoSmithKline which is expected to treat in inhalational anthrax. Raxibacumab is an injectable medicine which was developed by the Human Genome Sciences.
This drug has been granted the orphan status by FDA. Any drug is designated orphan if the disease treated by it is affecting less than 200,000 Americans. Raxibacumab is expected to neutralize the toxins produced by inhalation of spores of a kind of anthrax bacteria.
It is the first monoclonal drug to be approved by FDA under its Animal Efficacy Rule. The rule suggests the approval of drugs based on its trials conducted on animals while it feels that testing the drug on humans is not ethical.
The drug was approved by the health regulator in Friday against inhalational anthrax caused by Bacillus Anthracis bacteria. Now the drug can be used for the treatment of adults and pediatric patients with the disease.
Anthrax is a disease that occurs rarely but is very lethal. It is caused by toxin producing bacteria. "Although antibiotics are approved to prevent and treat anthrax infection, raxibacumab is the first approved agent that acts by neutralizing the toxins produced by B. anthracis", said Edward Cox, MD, the Director of the 0ffice of antimicrobial products at the FDA.