Gammaplex Approved for PI Patients 2 Years and Older
- By BSTQ Staff
In August, the U.S. Food and Drug Administration (FDA) approved Bio Products Laboratory’s Gammaplex (immune globulin intravenous [human] 5% liquid) for pediatric patients 2 years of age and older who have primary immunodeficiency disease (PI). The approval was based on study data submitted as part of a post-marketing commitment following the approval of Gammaplex for adults in 2009. In the study, 25 children and adolescents with PI aged 3 years to 16 years were treated with Gammaplex for 12 months. During the study, two serious acute bacterial infections (SABIs) of pneumonia were reported, resulting in an annual SABI event rate of 0.09, well below the maximum SABI event rate of 0.5 per subject required for approval. At some point during the study, 14 children had an adverse reaction that was considered product-related. Of those, two had adverse reactions that were considered definitely related to Gammaplex, including headache, fatigue and myalgia. The most common adverse reactions, occurring in less than 5 percent of children, were dyspnea, otitis media acute and tonsillar disorder (two). Two subjects reported a serious adverse event of lobar pneumonia. Neither serious adverse reaction was considered related to Gammaplex, and neither met FDA-defined SABI criteria.
