Green Cross 'Aliglo', FDA Approval Decision to Be Made in January Next Year

GC Green Cross's blood product 'Aliglo (Intravenous Immunoglobulin (IVIG-SN) 10%, development code GC5170B)' is expected to have its approval decision by the U.S. Food and Drug Administration (FDA) in January next year.

GC Green Cross announced on the 31st that with the FDA's full-scale review process for Aliglo underway, the final decision deadline for approval under the Prescription Drug User Fee Act (PDUFA) has been set for January 13 next year (local time).

Aliglo is one of GC Green Cross's representative blood products used for various indications including Primary Humoral Immunodeficiency. In a Phase 3 clinical trial involving 49 participants, the primary efficacy endpoint?the annual rate of serious bacterial infections (SBI)?was evaluated at 0.02 per patient per year, meeting the evaluation criteria. In terms of safety, the rate of temporally associated adverse events (TAAEs) occurring within 72 hours post-administration was 0.24, satisfying the predefined evaluation criteria, and no serious adverse reactions were reported.

As of 2021, the U.S. immunoglobulin market was known to be worth $10.4 billion (approximately 13 trillion KRW), and demand continues to increase due to a rise in autoimmune disease patients. However, blood products require large-scale facility investments and advanced production experience, resulting in a very limited number of producers and frequent supply shortages. In response, GC Green Cross plans to expand the market by launching Aliglo overseas.

GC Green Cross Chungbuk Ochang Factory
Photo by GC Green Cross

This FDA approval application for Aliglo is a re-submission. A Biologics License Application (BLA) was previously submitted in February 2021, but due to the COVID-19 pandemic, on-site inspections became difficult, leading to a 'remote evaluation' of the production facility. Consequently, in February last year, a Complete Response Letter (CRL) was issued requiring an on-site inspection. Following an on-site inspection of the Ochang plant in Chungbuk last April, the BLA was resubmitted to the FDA on the 14th (local time).

The company plans to launch Aliglo under its brand in the U.S. market next year after receiving final FDA approval.

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