The FDA is pushing back the approval of GC Pharma’s blood derivative ALYGLO (IVIG-SN 10%) in a complete response letter that cited a delay in the on-site inspection of the company’s manufacturing facility.
ALYGLO is a liquid immunoglobulin preparation purified from plasma fractions and has been developed for the treatment of primary immunodeficiency diseases such as congenital immunodeficiency syndrome and immune thrombocytopenia.
GC Pharma, formerly known as Green Cross Corporation, said the CRL was based on the failure to conduct an inspection of the plant in Ochang, Chungbuk, South Korea, within the agency's target period. Due to travel restrictions related to the pandemic, the FDA conducted Remote Interactive Evaluations in the fourth quarter of 2021, the company said.
“We will continue to communicate with the FDA to coordinate the required onsite inspection as soon as possible,” Eun-chul Huh, president of GC Pharma, said in a statement.
The company added that it has submitted all the required documents for its application and that ‘GC5107’ had positive results in a phase 3 study conducted in North America, “meeting its primary efficacy and safety endpoints for FDA guidance requirement.”
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After nearly two years of inspection delays due to restrictions put in place because of the COVID-19 pandemic, the FDA resumed domestic inspections in early February.
The agency has said it will move forward with previously planned foreign inspections that have country clearance and fall within the Centers for Disease Control and Prevention's Level 1 or Level 2 COVID-19 travel recommendations. South Korea is currently listed by the CDC as Level 4, a very high-risk destination. The FDA plans more foreign inspections starting in April as part of its goal for restarting prioritized inspections overseas.