An injectable drug for the treatment of inhalation anthrax has been recommended by the Anti-Infective Drugs Advisory Committee for Food and Drug Administration (FDA) approval, according to a GlaxoSmithKline press release Nov. 2.
The drug, raxibacumab injection, is a monoclonal antibody targeting the protective antigen (PA) component of the lethal toxin of Bacillus anthracis and is being developed for the treatment of inhalational anthrax.
The Anti-Infective Drugs Advisory Committee to the US Food and Drug Administration (FDA) voted 16 to 1 in support of the clinical benefit of raxibacumab for the treatment of inhalational anthrax, with one abstention. In addition, the committee voted 18 – 0 in favor of the risk-benefit profile of raxibacumab.
Senior Vice President and Head of Infectious Diseases, GlaxoSmithKline, Zhi Hong said, “Anthrax has been identified by the US Government as a serious potential threat and there is a need for new treatment options in the event of an anthrax attack in the US.
“The development of raxibacumab reflects a collaboration of industry and government in response to this public health need, and we are pleased with the outcome of today’s meeting which represents years of dedication to this project by Human Genome Sciences”
According to the National Institutes of Health, inhaled anthrax is particularly deadly. Although the spores are dormant when breathed in, they germinate when exposed to a warm, moist environment, such as the lungs. Not all particles are small enough to pass into the alveoli, or air sacs, but those that do begin to multiply and may spread to the lymphatic system. When the spores germinate in the lymph nodes, several toxins are released.
The Anti-Infective Drugs Advisory Committee reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of infectious diseases and disorders and make appropriate recommendations to the Commissioner of Food and Drugs.
The final decision of the FDA on raxibacumab is set for December 15, 2012. The FDA normally considers the recommendations of the panel though it is not bound to do so.
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