The extension study was aimed to assess the tolerability and safety of Privigen, when administered at infusion rates higher than those of the pivotal study (12mg/kg/min, as opposed to 8mg/kg/min). Results showed that Privigen is well-tolerated at high infusion rates with no temporally associated adverse events requiring an infusion rate reduction or termination during the study. This higher infusion rate may translate into less time spent in the hospitals for patients.
The pivotal study aimed to assess the safety and efficacy in patients with primary immune deficiencies (PI). Privigen met all pre-defined efficacy and safety endpoints.