Panzyga® for patients with Primary immuno­deficiency syndrome (PID)

PID refers to a large heterogeneous group of disorders that result from mostly inherited defects in the development and/or function of the immune system.1 Almost 500 different PIDs have been described so far, with more than 6 million people affected around the world.2 Around 60% of all PID cases are associated with hypogammaglobulinemia due to impaired antibody production.3 Whilst it is estimated that most of PIDs could be easily diagnosed with simple and inexpensive blood tests, many PIDs remain underdiagnosed on a global scale, leaving people affected at high risk of infections, severe autoinflammation, autoimmunity, allergy, and malignancy.4,5
IVIg replacement therapy can help address the key needs of patients with PIDs, such as:
↓ number of severe infections6,7
↓ days of antibiotic use6
↓ rate and duration of hospitalisation6,7
↑ quality of life7,8

Trial overview9

Efficacy

Proven efficacy that satisfies the requirements of regulatory authorities for IVIg replacement therapy9–11

Tolerability

A well demonstrated safety and tolerability profile across all age groups and treatment intervals9

The most common AEs were (N=51):

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).

Proportion of patients with TEAEs9

IVIg, immunoglobulin solution for intravenous infusion.

References

1. McCusker C, et al. Allergy Asthma Clin Immunol 2018;14:61;

2. Tangye SG, et al. J Clin Immunol 2022;42:1473–1507;

3. Krivan G, et al. Am J Clin Exp Immunol 2017;6:76–83;

4. IPOPI. What are Primary Immunodeficiencies (PIDs)? Available at: https://ipopi.org/pids/what-are-pids/; accessed July 2023;

5. Bousfiha A, et al. J Clin Immunol 2020;40:66–81;

6. Modell V, et al. Immunol Res 2011;51:61–70;

7. Wood P. Ther Clin Risk Manag 2012;

8. Espanol T, et al. Patient Prefer Adherence 2014;

9. Borte M, et al. J Clin Immunol 2017;37:603–612;

10. 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;

11. 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.

This is an international website for Panzyga® and is intended for healthcare professionals outside the US. The information on this site is not country-specific and may contain information that is outside the approved indications in the country in which you are located.
IMPORTANT: The information on this website is based on the European Summary of Product Characteristics (EU SmPC).
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