Delay in On-site Inspection Due to COVID-19 Impact
Finally Received CRL in February Last Year
On-site Inspection Conducted at Ochang Plant in April
"Approval Expected Early Next Year, Launch Targeted for Second Half"
GC Green Cross's blood product 'Aliglo (Intravenous Immunoglobulin 10%·IVIG-SN 10%)' is challenging a resubmission for approval from the U.S. Food and Drug Administration (FDA).
GC Green Cross announced on the 17th that it resubmitted the Biologics License Application (BLA) for Aliglo to the FDA on the 14th (local time). The BLA for Aliglo was originally submitted in February 2021. However, due to the COVID-19 pandemic, on-site inspections became difficult, and the production facility evaluation was conducted through a 'remote assessment.' As a result, in February last year, the company received a final Complete Response Letter (CRL) requesting an on-site inspection. Following an on-site inspection of the Ochang plant in Chungbuk in April, the company proceeded with this BLA resubmission.
GC Green Cross stated that it has already submitted all necessary documents for U.S. approval, including materials related to the production facility on-site inspection, to the FDA. Aliglo has met all efficacy and safety evaluation variables in accordance with FDA guidelines through the North American Phase 3 clinical trial completed in 2020.
Aliglo is one of GC Green Cross's representative blood products used for various indications, including Primary Humoral Immunodeficiency. In the Phase 3 clinical trial involving 49 subjects, the primary efficacy endpoint?the annual rate of acute serious bacterial infections (SBI) per patient?was evaluated at 0.02, meeting the assessment criteria. Regarding 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 events were reported.
The FDA's approval process involves a preliminary review after BLA submission, and if the data are deemed appropriate, a target review completion date is set to commence the full review process. The target review completion date is expected in the first half of next year.
The U.S. immunoglobulin market was estimated to be approximately KRW 12.5 trillion as of 2021. With the recent increase in autoimmune disease patients, demand for immunoglobulin continues to grow. However, blood products require large-scale facility investments and advanced production experience, limiting the number of producers and often causing supply shortages. Therefore, market expansion through the overseas launch of Aliglo is highly anticipated.
A GC Green Cross official stated, “We aim to receive product approval early next year and launch in the U.S. market in the second half of the year,” adding, “We will leverage our entry into the U.S. market as a stepping stone to become a global leader in blood products.”
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