The U.S. Food and Drug Administration has entered a full review of GC Pharma’s intravenous immunoglobulin therapy GC5107 for regulatory clearance, with the date of review completion set on February 25, 2022, the Korean company said on Tuesday.
GC Pharma submitted its biologics license application (BLA) for the therapy to the FDA in February. In general, the FDA has a 60-day filing review period to determine whether GC Pharma’s application is complete and acceptable for filing.
According to GC Pharma, GC5107 is a blood product used for the treatment of congenital immunodeficiency disorder and immune thrombocytopenia. Blood products are medicines obtained through separation and purification of specific proteins from blood plasma.
According to the concentration of immunoglobulins that strengthen the immune system, immunoglobulin preparations are classified into two types: 5 percent and 10 percent products. GC5107 is a high-concentration 10 percent product.
GC Pharma said it will be able to launch the product in the US in the second half of next year if it is approved by the FDA as expected.
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