Hizentra has been on the market for 13 years, 8 months, and 19 days as of November 24, 2023.
Hizentra (immune globulin subcutaneous [human], 20% liquid) received its initial approval from the U.S. Food and Drug Administration (FDA) on March 5, 2010. This marked a significant milestone as it was the first 20 percent subcutaneous immunoglobulin (SCIG) therapy available at the time.
Understanding Hizentra's Market Presence
Hizentra, developed by CSL Behring, is a crucial treatment for patients with certain primary immunodeficiency (PI) conditions. Its approval provided a new, more concentrated option for home-based self-administration, offering convenience and flexibility compared to intravenous infusions.
Key Approval Details:
| Feature | Detail |
|---|---|
| Product Name | Hizentra (Immune Globulin Subcutaneous [Human], 20% Liquid) |
| Manufacturer | CSL Behring |
| FDA Approval Date | March 5, 2010 |
| Significance | First 20 percent subcutaneous immunoglobulin (SCIG) therapy approved by the FDA |
What is Hizentra Used For?
Hizentra is primarily used to treat primary immunodeficiency (PI) in adults and children two years of age and older. PI is a group of more than 450 rare, chronic disorders in which part of the body's immune system is missing or functions improperly.
Benefits of Subcutaneous Immunoglobulin (SCIG) Therapy:
- Convenience: Allows for self-administration at home, reducing the need for frequent clinic visits.
- Flexibility: Patients can administer the therapy on a schedule that fits their lifestyle.
- Steady-state levels: Helps maintain consistent immunoglobulin levels in the body, which can lead to fewer peaks and troughs compared to intravenous infusions.
For more detailed information on Hizentra and its FDA approval history, you can visit Drugs.com.
