GC Biopharma Receives the US FDA Approval for Alyglo (GC5107B),10% Liquid for the treatment of Primary Humoral Immunodeficiency (PI)
Shots:
- The Approval was based on the P-III study evaluating the safety & efficacy of GC5107B for the treatment of adult patients aged 17 years & older with primary humoral immunodeficiency (PI)
- The result of the study depicted 1EP of 0.03 aSBIs per patient-year, meeting the FDA requirement of <1 aSBI per patient-year. The proportion of infusions with AEs within 72 hrs. after the infusion was 0.22, meeting the FDA-required endpoint of less than 0.40
- Alyglo, a 10% IgG liquid for IV infusion, is sourced from human plasma. Its manufacturing process incl. fractionation, solvent/detergent treatment, and nanofiltration.Cation Exchange Chromatography (CEX) is employed in the process
Ref: PR Newswire | Image: GC Biopharma
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
