Clinical Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Immunoglobulin Intravenous (Human) 10% (NewGam) in Patients With Primary Immunodeficiency Diseases

NewGam is a new 10% human normal immunoglobulin (IVIG) solution developed by Octapharma for
intravenous administration. It is supplied as a liquid formulation ready to use. IVIG has
proved to be useful in a variety of clinical conditions other than for replacement of
immunoglobulins, in which IVIG exhibits an immunomodulatory effect. Children and adults with
PID have an increased risk of getting recurrent bacterial and viral infections that
typically attack the respiratory tract (sinusitis, bronchitis, pneumonia) but can also
affect the gastrointestinal tract (gastroenteritis). They can be severe and can lead to
substantial morbidity. Responses to antibacterial therapy are often poor. At present, most
primary immune deficiencies are not curable, but IVIGs have been shown to decrease the total
number of severe infections and the duration of hospitalization.