Approved: First Botulism Antitoxin to Treat Seven Serotypes

The FDA announced that it has approved Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G [equine]; Cangene) to treat patients showing signs of botulism following documented or suspected exposure to botulinum neurotoxin.  This antitoxin is derived from horse plasma and contains a mixture of antibody fragments that neutralize all seven serotypes known to cause botulism.

Botulism manifests as severe muscle weakness that progresses from the head to the rest of the body. If untreated, it may progress to total loss of muscle function and inability to breathe. This heptavalent antitoxin is the only product available for the treatment of botulism in adults, and for infant botulism caused by nerve toxins other than types A and B. BabyBIG [botulism immune globulin intravenous [human]) is currently available to treat infant botulism caused by toxin types A or B in patients <1 year of age.

The effectiveness of the product was studied in animals because it was not feasible or ethical to conduct efficacy studies in humans. These results provided substantial evidence that the antitoxin is reasonably likely to benefit humans with botulism. The safety of the heptavalent antitoxin was tested in 40 healthy human volunteers and also monitored in 228 patients who received the antitoxin experimentally under the CDC's botulism treatment program.

The antitoxin will be maintained in the Strategic National Stockpile and distributed through the CDC's Drug Service.

For more information call (888) INFO-FDA or visit www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm345128.htm.