GlaxoSmithKline (GSK) has obtained FDA approval for raxibacumab monoclonal anti-toxin to treat inhalational anthrax, caused by Bacillus anthracis, in both adults and children.
Raxibacumab, discovered and developed at Human Genome Science (HGS), was approved as a combination therapy along with appropriate antibacterial drugs and for prophylaxis of inhalational anthrax.
GlaxoSmithKline infectious diseases head and senior vice president Zhi Hong said raxibacumab is a part of an ongoing GSK and US government alliance focused on various public health concerns.
"It will be an important addition to the new approaches required to address our critical biodefense needs," Hong said.
Raxibacumab's effectiveness was established in studies conducted in animal models, while its safety was studied in 326 healthy adult volunteers treated with the recommended dose.
An improved survival rate over control in two relevant animal models, both in combination with antibiotics and alone, was observed in raxibacumab studies.
A single 40mg/kg dose intravenous administration of raxibacumab is recommended for adults for a period of two hours and 15 minutes while the recommended paediatric dose depends on the weight of the children.
Diphenhydramine should be administered within an hour of treatment for the reduction of the risk of infusion reactions.
HGS development and regulatory affairs senior vice president Sally Bolmer said; "Our development program charted new territory in terms of the science and the regulatory pathway and was a result of our successful collaboration with the Biomedical Advanced Research and Development Authority (BARDA) and FDA."
Image: GSK Raxibacumab is the first monoclonal anti-toxin to be approved by the FDA for inhalational anthrax. Photo: Courtesy of Maxwell Hamilton.