Green Cross’ Immunodeficiency Drug Accepted for Review by US FDA

Green Cross Corporation, a South Korean biopharmaceutical company, announced on Jan. 26 that the United States Food and Drug Administration (FDA) has accepted for review its biologics license application (BLA) for IVIG-SN, or human normal immunoglobulin G for intravenous administration.

Once the application is submitted, the U.S. FDA makes a decision within 60 days of the BLA submission whether to accept submitted data. When the data is insufficient, the U.S. FDA returns the BLA. When data is sufficient, it fixes the targeted review completion date and examines submitted data in earnest.

According to the procedure, on Jan. 22 (local time), the U.S. FDA accepted the Green Cross’ BLA for IVIG-SN, which was submitted in November last year. It is scheduled to complete its review of IVIG-SN within the fourth quarter of this year.

Exclusively developed by Green Cross, IVIG-SN is one of the most popular blood products which are used to treat various diseases, such as primary immunodeficiency disorders and immune thrombocytopenia. IVIG-SN racked up some 60 billion won (US$49.79 million) in sales in markets at home and abroad last year.