Manufactured from pooled human plasma from American donors, Alyglo is a liquid solution with 10% immunoglobulin G (100 mg/mL) for intravenous infusion
The FDA has approved GC Biopharma’s Alyglo for primary humoral immunodeficiency. (Credit: Myriams-Fotos from Pixabay)
GC Biopharma has secured approval from the US Food and Drug Administration (FDA) for Alyglo (immune globulin intravenous, human-stwk) 10% Liquid for the treatment of primary humoral immunodeficiency (PI).
Alyglo, formerly known as GC5107, is a liquid solution with 10% immunoglobulin G (100 mg/mL) for intravenous infusion. It is made from pooled human plasma from American donors.
The FDA has approved Alyglo for adult patients aged 17 years and older with primary humoral immunodeficiency.
The approval was based on the results from the ALYGLO Phase 3 clinical study, conducted in both Canada and the US.
The prospective, open-label, single-arm, historically controlled, multicentre trial evaluated the safety and effectiveness of the liquid solution in patients having a confirmed diagnosis of primary humoral immunodeficiency.
The results showed a rate of 0.03 acute serious bacterial infections (aSBIs) per patient-year, which was the primary efficacy endpoint of the study. This was equal to the FDA efficacy requirement of less than one aSBI per patient-year.
In terms of safety, the proportion of infusions with temporally associated adverse events occurring during or within 72 hours after infusion was observed at 0.22. This data met the FDA-mandated prespecified endpoint of less than 0.4.
Furthermore, secondary analyses were the annual rate or days of other illnesses, the usage of antibiotics, the number of days missed from work, school, or daycare because of an infection, and the number of days spent in the hospital because of infection.
GC Biopharma president and CEO Eun-chul Huh 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.
“We are pleased to offer patients another important treatment option in the coming months that is both safe and effective.”
According to GC Biopharma, Alyglo removes coagulation factor XIa (FXIa) to undetectable quantities in the manufacturing process by using Cation Exchange Chromatography (CEX).