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Breakthrough Immunoglobulin Therapy Yimmugo® Now Available in the U.S.

Published: 7/1/2024
      
Yimmugo®
immunoglobulin therapy
primary immunodeficiencies
PID
Kedrion Biopharma
Biotest AG
FDA approval
plasma-derived therapies
immune system
IVIg

Key Takeaways

  • Yimmugo® is a newly FDA-approved immunoglobulin therapy for primary immunodeficiencies.
  • Kedrion Biopharma will distribute Yimmugo® in the U.S. starting in early 2025.
  • The production of Yimmugo® takes place in a state-of-the-art laboratory in Germany.

Did You Know?

Primary immunodeficiencies affect approximately 500,000 people in the United States.

Kedrion Biopharma Partners With Biotest AG

Kedrion Biopharma Inc. has recently announced a significant partnership with Biotest AG to distribute the newly FDA-approved immunoglobulin therapy Yimmugo® in the U.S. The FDA granted the approval of Yimmugo® on June 13, 2024, which marks a vital development in the treatment options available for primary immunodeficiencies (PID).

With the agreement in place, Kedrion Biopharma is expected to start the commercialization and distribution of Yimmugo® by the beginning of 2025. Biotest will supply Yimmugo® starting in the fourth quarter of 2024.

What is Yimmugo®?

Yimmugo® is a polyvalent immunoglobulin G preparation derived from human blood plasma, designed for intravenous administration. It is specifically intended for patients aged two years and above who suffer from primary immunodeficiencies (PID). This group of disorders affects around 500,000 individuals in the United States.

The primary function of Yimmugo® is to enhance the immune system, thereby preventing infections and improving overall quality of life for patients with compromised immune systems.

High-Tech Production Facility

Yimmugo® is produced in Biotest’s state-of-the-art

References

  1. FDA Approves Yimmugo®
    https://www.fda.gov/news-events/press-announcements/fda-approves-yimmugo
  2. Primary Immunodeficiency (PID): Symptoms and Treatment
    https://www.nih.gov/health-information/primary-immunodeficiency-symptoms-treatment
  3. Kedrion Biopharma Official Website
    https://www.kedrion.com
  4. Biotest AG Official Website
    https://www.biotest.com