A Comprehensive Monograph on Equine Botulinum Neurotoxin G Immune FAB2 (DB13899) and its Clinical Application within the Heptavalent Antitoxin (BAT®) Formulation

Executive Summary

Equine Botulinum Neurotoxin G Immune FAB2, identified by DrugBank Accession Number DB13899, is a biotechnology-derived therapeutic agent crucial for the management of botulism, a rare but potentially fatal neuroparalytic illness. This agent is not administered as a standalone product but serves as an indispensable component of a broader-spectrum antitoxin, Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) – (Equine), commercially known as BAT®. This heptavalent formulation is the only therapeutic licensed by the U.S. Food and Drug Administration (FDA) for treating symptomatic botulism arising from any of the seven known botulinum neurotoxin serotypes in adults and pediatric patients.[1]

The antitoxin is composed of polyclonal F(ab')2 immune globulin fragments, which are purified from the plasma of horses hyperimmunized with botulinum toxin serotype G toxoid.[3] The manufacturing process involves enzymatic digestion to remove the immunogenic Fc portion of the antibody, a process known as "despeciation," which significantly enhances the product's safety profile by reducing the risk of hypersensitivity reactions.[5] The mechanism of action is direct and extracellular; the F(ab')2 fragments bind with high affinity to free, circulating botulinum neurotoxin G, preventing its attachment to presynaptic nerve terminals and subsequent internalization, thereby neutralizing its toxic effects before paralysis can progress.[3]