Regulatory Decision Summary for Flebogamma 5% / Flebogamma 10%

Data submitted in this New Drug Submission (NDS) establish a substantial likelihood of product benefit in the target population of adults and children with PID and ITP. There currently do not appear to be any additional clinically significant risks with the use of the product over other IVIG products currently marketed; therefore, the overall benefit-risk profile is favorable.

Treatment with intravenous immunoglobulin (IVIG) at doses between 200-600 mg/kg of weight every 2-4 weeks increases serum levels of IgG to a level well above 4-6 g/L, which are the minimum values regarded as suitable for avoiding infections in immunodeficient patients. The dose must be individualised in each patient based primarily on the clinical course of the disease and the response to the treatment.

For autoimmune conditions, according to a Cochrane systematic review, moderate-quality evidence shows that patients treated within two weeks from onset of symptoms with IVIG had recovery similar to that of plasma exchange (PE). This review also found that patients treated with IVIG tended to have fewer adverse events, fewer treatment complications, and were less likely to discontinue therapy as compared with PE.