Alyglo FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 31, 2024.
FDA Approved: Yes (First approved December 15, 2023)
Brand name: Alyglo
Generic name: immune globulin intravenous, human-stwk
Dosage form: Liquid for Intravenous Injection
Company: GC Biopharma USA, Inc.
Treatment for: Primary Immunodeficiency Syndrome
Alyglo (immune globulin intravenous, human-stwk) is a 10% immune globulin liquid for intravenous injection indicated for the treatment of primary humoral immunodeficiency (PI) in adults.
- Primary humoral immunodeficiency (PI) is a group of disorders characterized by an impaired ability to produce antibodies, which leads to an increased susceptibility to infection, especially bacterial infections affecting the respiratory and gastrointestinal tracts.
- Alyglo is an immunoglobulin replacement therapy that works to treat PI by boosting the immune system.
- Alyglo contains immunoglobulin G (100 mg/mL) for intravenous infusion and is manufactured from pooled human plasma from US donors.
- Alyglo is administered by intravenous infusion every 21 or 28 days.
- Warnings and precautions associated with Alyglo include hypersensitivity and anaphylactic reactions, thrombotic events, risk of impaired renal function in at risk patients, aseptic meningitis syndrome, hemolysis, and pulmonary adverse reactions (transfusion-related acute lung injury).
- Common adverse reactions include headache, nausea/vomiting, fatigue, nasal/sinus congestion, rash, arthralgia, diarrhea, muscle pain/aches, infusion site pain/swelling, abdominal pain/discomfort, cough, and dizziness.
Development timeline for Alyglo
| Date | Article |
|---|---|
| Dec 17, 2023 | Approval FDA Approves Alyglo (Immune Globulin Intravenous, Human-stwk) 10% Liquid for Adults with Primary Humoral Immunodeficiency (PI) |
Further information
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