panzyga® for patients with Primary immunodeficiency syndrome
The efficacy and tolerability of panzyga® in patients with primary immunodeficiency (PID) were evaluated in the pivotal study NGAM-01 (NCT01012323), a 12-month Phase III study and its 3-month extension study NGAM-05 (NCT01313507).
Efficacy
Proven efficacy that satisfies the requirements of regulatory authorities for IVIg replacement therapy9–11
panzyga® effectively ...
prevents occurrence of serious bacterial infections (SBIs)9
improves quality of life9
restores immunoglobulin G levels to normal range9
Tolerability
A well demonstrated safety and tolerability profile across all age groups and treatment intervals9
The most common AEs were (N=51):
No haemolysis observed9
No thrombotic events observed9
No serious treatment-emergent adverse events (TEAEs)9
Uncompromised tolerability even at higher infusion speed9
Patients who tolerated an infusion rate of 0.08 ml/kg/min in the main study, continued in the extension study NGAM-05 (N=21). Over 90% of those patients were infused at 0.14 ml/kg/min.
The average duration of each infusion was 2.2 hours (132 minutes) in the main study compared to the extension study, 1.5 hours (90 minutes) demonstrating a significant infusion duration time saving for patients (42 minutes on average).
9. Borte M, et al. J Clin Immunol 2017;37:603–612.
Proportion of patients with TEAEs9
Uncompromised tolerability and no serious TEAEs observed in the extension study with higher rates of infusion9
panzyga® for your patients
IVIg, immunoglobulin solution for intravenous infusion.
References
McCusker C, et al. Allergy Asthma Clin Immunol 2018;14:61;
Tangye SG, et al. J Clin Immunol 2022;42:1473–1507;
Krivan G, et al. Am J Clin Exp Immunol 2017;6:76–83;
IPOPI. What are Primary Immunodeficiencies (PIDs)? Available at: https://ipopi.org/pids/what-are-pids/; accessed July 2023;
Bousfiha A, et al. J Clin Immunol 2020;40:66–81;
Modell V, et al. Immunol Res 2011;51:61–70;
Wood P. Ther Clin Risk Manag 2012;
Espanol T, et al. Patient Prefer Adherence 2014;
Borte M, et al. J Clin Immunol 2017;37:603–612;
FDA. Guidance for Industry. Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency. June 2008. Available at: https://www.fda.gov/media/124333/download; accessed July 2023;
EMA. Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg). December 2021. Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-human-normal-immunoglobulin-intravenous-administration-ivig-rev-4_en.pdf; accessed July 2023.
