| Drug Name |
YIMMUGO® (immune globulin intravenous, human-dira) Liquid for Intravenous Injection |
| Active Ingredient |
immune globulin intravenous, human-dira |
| Date of Approval |
6/13/2024
Approved in Europe in 2022 |
| Manufacturer |
Grifols USA, LLC |
| Approval Pathways and Indications |
Approval Pathway: BLA
Indication: YIMMUGO® is an immune globulin intravenous, human - dira, 10% liquid indicated for the treatment of primary humoral immunodeficiency (PI) in patients 2 years of age or older. |
| Therapeutic Class |
Immune Globulin |
| Formulation |
Liquid for Intravenous Injection |
| MoA |
YIMMUGO® provides a broad spectrum of opsonizing and neutralizing immune globulin G (IgG) antibodies against a wide variety of pathogens and their toxins, which helps to avoid recurrent serious opportunistic infections. The mechanism of action has not been fully elucidated but may include immunomodulatory effects. |
| Dosing and Administration |
YIMMUGO® is a solution containing 10% IgG (100 mg/mL): 5 g in 50 mL, 10 g in 100 mL, 20 g in 200 mL.
For the 1st infusion, the dose is 300-800mg/kg(3-8mL/kg) every 3 - 4 weeks at an initial infusion rate of 0.5 mg/kg/min (0.005 mL/kg/min) for 30 minutes with a maintenance infusion rate that is gradually increased to every 30 minutes if tolerated of 3.0 mg/kg/min (0.03 mL/kg/min).
For all future infusions, the dose is 300-800mg/kg(3-8mL/kg) every 3 - 4 weeks at an initial infusion rate of 0.5 mg/kg/min (0.005 mL/kg/min) for 30 minutes with a maintenance infusion rate that is gradually increased to every 30 minutes if tolerated of 13.0 mg/kg/min (0.13 mL/kg/min). |
| Administered by self or by HCP |
Administered by HCP |
| Place in Therapy |
YIMMUGO® is the first of a threesome of Biotest plasma proteins on the horizon. The other two, both in late-stage development, are a fibrinogen concentrate (FC) to treat acquired fibrinogen deficiency – it would be the first FC approved for this indication in the U.S. – and trimodulin, a polyvalent Ig to treat community-acquired pneumonia (CAP) or severe community-acquired pneumonia (sCAP).
The sugar-free ready-to-use solution is approved for substitution therapy in primary antibody deficiency syndromes. Primary humoral immunodeficiency involves a diminished ability to produce antibodies, heightening susceptibility to bacterial infections affecting the respiratory and gastrointestinal systems. Derived from human blood, YIMMUGO® contains a variety of immunoglobulin G (IgG) antibodies that combat a broad spectrum of pathogens and toxins, reducing the risk of severe, recurrent infections in PI patients. It's important to note that YIMMUGO® may potentially contain infectious agents like viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. |
| Expected Market Launch Date |
Availability is anticipated fall of 2024. |
| New Molecular Entity (NME) or Existing Formulation |
Existing Formulation |
| Expected Cost |
Unavailable |
| Product Discontinuation |
N/A |
| Clinical Trials |
Trial 991 (NCT02810444) assessed YIMMUGO® as replacement therapy for PI in a prospective, open-label, multicenter, multinational study involving 67 patients aged 2 to 75 years who had stable IgG levels on intravenous immunoglobulin (IGIV) therapy for at least 3 months. The mean age was 35 years, with 18 pediatric patients and 5 elderly patients enrolled. YIMMUGO® was administered every 3 weeks or 4 weeks over approximately 12 months, starting at low doses and adjusting based on tolerability. The primary endpoint, serious bacterial infections (SBI) rate over 12 months, aimed for less than one acute SBI per patient per year. None of the 18 pediatric patients experienced an SBI. Two serious adverse events (SAEs) related to YIMMUGO® occurred (anaphylactic reaction and severe neutropenia), leading to treatment discontinuation. Mild hemolysis and a positive Coomb’s test were also reported in one patient. Common adverse reactions included headache, upper respiratory tract infections, fatigue, nausea, and increased blood pressure. Overall, Trial 991 demonstrated YIMMUGO® effectively reduced SBI in PI patients, meeting efficacy criteria, but highlighted the need for vigilant monitoring and dose adjustment due to associated serious adverse events. |
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Drugs.com. Yimmugo Approval History. Available at: https://www.drugs.com/history/yimmugo.html. Accessed June 21, 2024.
U.S. Food and Drug Administration. Yimmugo [package insert]. Available at: https://www.fda.gov/media/179364/download?attachment. Published June 2023. Accessed June 21, 2024.
U.S. Food and Drug Administration. Yimmugo Risk Evaluation and Mitigation Strategy (REMS). Available at: https://www.fda.gov/media/179371/download?attachment. Published June 2023. Accessed June 21, 2024.
Drugs.com. FDA Approves Yimmugo (immune globulin intravenous [human]) for DIRA and Primary Immunodeficiencies. Available at: https://www.drugs.com/newdrugs/fda-approves-yimmugo-immune-globulin-intravenous-human-dira-primary-immunodeficiencies-6304.html. Published June 2024. Accessed June 21, 2024. |