By SPC News Staff
The FDA granted a new indication for cutaquig (immune globulin, subcutaneous [Human]-hipp, 16.5% Solution; Octapharma) for the treatment of pediatric patients age 2 years and older with primary humoral immunodeficiency (PI).
The FDA previously approved cutaquig for adults with PI.
The new indication is based on the results of two clinical trials, which involved 75 PI patients: 37 adults and 38 children between 24 months and 17 years of age. The patients received weekly