What is BabyBIG®?
BabyBIG®, Botulism Immune Globulin Intravenous (Human) (BIG-IV), is an orphan drug that consists of human-derived anti-botulism toxin antibodies that is approved by the U.S. Food and Drug Administration for the treatment of infant botulism types A and B.

The product is a solvent-detergent-treated, sterile, lyophilized powder of immunoglobulin G (IgG), stabilized with 5% sucrose and 1% albumin (human). It contains no preservative. The purified immunoglobulin is derived from pooled adult plasma from persons immunized with recombinant botulinum vaccine for serotypes A and B (rBV A/B) who were selected for their high titers of neutralizing antibody against botulinum neurotoxins type A and B. All donors were tested and found negative for antibodies against the human immunodeficiency virus and the hepatitis B and hepatitis C viruses. The pooled plasma was fractionated by cold ethanol precipitation of the proteins according to the Cohn/Oncley method and modified to yield a product suitable for intravenous administration.

To date, use of BabyBIG® to treat more than 2,180 US infant botulism patients has resulted in more than 128 years of avoided hospital stay and more than $174 million of avoided hospital costs. On average, infant botulism patients have an approximately 3.6 week reduction in time spent in the hospital, resulting in over $94,000 in avoided hospital costs (when compared to the pivotal clinical trial placebo group).

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