GC Biopharma: FDA Approves ALYGLO 10% Liquid To Treat Primary Humoral Immunodeficiency

GC Biopharma: FDA Approves ALYGLO 10% Liquid To Treat Primary Humoral Immunodeficiency

December 18, 2023

South Korea’s GC Biopharma Corp. announced Monday that the US Food and Drug Administration has approved ALYGLO (immune globulin intravenous, human-stwk) 10% Liquid, formerly referred to as GC5107, for the treatment of adult patients aged 17 years and older with primary humoral immunodeficiency or PI.

The ALYGLO pivotal phase 3 clinical study followed FDA guidance for the treatment of patients with PI, which refers to a group of disorders where the body’s ability to produce antibodies is impaired, affecting the immune system’s ability to fight infections.

The clinical trial (NCT02783482) GC5107B, a prospective, open-label, single-arm, historically controlled, multicenter phase 3 study, was to assess the efficacy and safety of GC5107B in patients with a confirmed diagnosis of PI. The studies were conducted in the U.S. and Canada.

The key findings from the trial include a primary efficacy end point of 0.03 acute serious bacterial infections (aSBIs) per patient-year, which met the FDA efficacy requirement of less than one aSBI per patient-year.

According to the company, the proportion of infusions with temporally associated adverse events occurring during or within 72 hours after infusion was 0.22, which met the FDA-required prespecified end point of less than 0.40.

Further, secondary analyses were annual rate or days of other infections, antibiotic use, days out of work/school/day care or unable to perform normal activities due to infection, and days of hospitalization due to infection.

Eun-chul Huh, President and CEO of GC Biopharma, said, “The approval of ALYGLO by the US FDA is a significant milestone for GC Biopharma and patients with primary immunodeficiency disease. It reinforces GC Biopharma’s commitment to patients and health care professionals by expanding our product portfolio globally to serve individuals with rare diseases.”

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