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GSK/HGS win US FDA OK for raxibacumab as 1st mAb in anthrax

 
• By Donna Young

GlaxoSmithKline and its subsidiary Human Genome Sciences not only won the US FDA's OK to market raxibacumab in combination with antibacterials as a treatment for adults and pediatric patients with inhalational anthrax, the companies also were granted approval to sell the medicine as a preventive therapy when alternative treatments are not available or appropriate.

GlaxoSmithKline and its subsidiary Human Genome Sciences not only won the US FDA's OK to market raxibacumab in combination with antibacterials as a treatment for adults and pediatric patients with inhalational anthrax, the companies also were granted approval to sell the medicine as a preventive therapy when alternative treatments are not available or appropriate.

Raxibacumab also is the first monoclonal antibody approved under the FDA's animal efficacy rule, which was created in 2002 to permit a drug's effectiveness to be demonstrated in animals when it is

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