Green Cross Blood Fractionation Products, FDA Approval Delayed

GC Green Cross Ochang Plant Panorama / Photo by Lee Chunhee

[Asia Economy Reporter Lee Chun-hee] The U.S. Food and Drug Administration (FDA) approval for GC Green Cross's immunoglobulin product 'ALYGLO' (domestic name 'Iviglobulin SN Injection 10%'), originally scheduled to be announced on the 25th (local time), has been delayed.

GC Green Cross announced on the 28th that it received a 'Complete Response Letter (CRL)' from the FDA regarding the Biologics License Application (BLA) for ALYGLO. A CRL is a request for additional actions sent by the FDA to a company during the approval process.

GC Green Cross explained that the sole reason for the approval delay was that the 'Pre-License Inspection' of the blood product manufacturing facility in Ochang, Chungbuk, was not conducted within the FDA's target review period. Due to the COVID-19 situation, the FDA conducted a 'remote evaluation' of Green Cross's manufacturing facility in the fourth quarter of last year.

The company stated, "Except for the on-site inspection of the manufacturing facility, all necessary documents required for the approval process have been submitted to the FDA," and added, "We are closely communicating with the FDA to find ways to expedite the on-site inspection." According to Green Cross, ALYGLO met all efficacy and safety evaluation variables in accordance with FDA guidelines in the North American Phase 3 clinical trial completed in 2020.

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