FDA Approves ALYGLO™ 10% for Adult Primary Immunodeficiency

GC Biopharma Corp  has received approval from the US Food and Drug Administration (FDA) for ALYGLO (immune globulin intravenous, human-stwk) 10% Liquid, formerly known as "GC5107," designed for treating adult patients aged 17 and above with primary humoral immunodeficiency (PI).

The FDA-approved pivotal phase 3 clinical study for ALYGLO, following FDA guidance for PI treatment, yielded positive results. The study, known as NCT02783482, was a prospective, open-label, single-arm, historically controlled, multicenter phase 3 study that assessed the efficacy and safety of GC5107B in patients with confirmed PI diagnoses in the United States and Canada. Key findings include:

1. Meeting the FDA efficacy requirement with a primary efficacy endpoint of 0.03 acute serious bacterial infections (aSBIs) per patient-year.
2. Achieving the prespecified endpoint with a proportion of infusions with temporally associated adverse events during or within 72 hours after infusion at 0.22.
3. Secondary analyses covering annual rates or days of other infections, antibiotic use, days out of work/school/day care, or inability to perform normal activities due to infection, and days of hospitalization due to infection.

Results of the phase 3 trial are published in Frontiers in Immunology (2021), and lead investigator Dr. Elena Perez emphasized ALYGLO's impact on clinical practice in the U.S., citing its strong safety and efficacy profile as crucial for primary immune-deficient patients.

ALYGLO utilizes novel Cation Exchange Chromatography (CEX) in its manufacturing process to remove coagulation factor XIa (FXIa) to undetectable levels, addressing concerns about thromboembolic events in patients receiving immunoglobulin infusions. GC Biopharma remains dedicated to enhancing product safety through ongoing evaluations of this manufacturing process.

Dr. Eun-chul Huh, President and CEO of GC Biopharma, sees the FDA approval as a significant milestone, reinforcing the company's commitment to rare disease patients globally by expanding its product portfolio.

ALYGLO, a liquid solution containing 10% immunoglobulin G (100 mg/mL), is manufactured from pooled human plasma from US donors, with a three-step process to reduce virus transmission risk. 

Primary Humoral Immunodeficiency (PI) encompasses disorders where antibody production is impaired, leading to increased susceptibility to infections. ALYGLO's indication for PI includes congenital agammaglobulinemia, common variable immunodeficiency (CVID), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

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