An immunodeficiency drug developed by Green Cross, a South Korean biopharmaceutical company, has been accepted for review by the U.S. Food and Drug Administration.
Green Cross said Tuesday that that FDA accepted the drugmaker’s biologics license application for IVIG-SN -- human normal immunoglobulin G for intravenous administration -- on Jan. 22.
IVIG-SN (Green Cross)
The news prompted the company’s stock price on the main Korean bourse KOSPI to surge by 2.01 percent on Tuesday to close at 228,000 won ($190).
The FDA is scheduled to complete its review of IVIG-SN within the fourth quarter of this year, according to the Korean drugmaker.
“IVIG-SN marks a major step toward our ultimate goal of expanding biologics business to the U.S. marketplace,” said Green Cross president Huh Eun-chul.
If the drug is approved by the FDA within this year, Green Cross expects to commercialize the drug in the U.S. by 2017 at the latest.
Exclusively developed by Green Cross, IVIG-SN treats primary immunodeficiency disorders which weaken or rids the immune system’s ability to fight infectious diseases.
The drug, already being sold in more than 30 countries in Asia, South America and the Middle East, is one of the firm’s top-selling plasma-based biologic treatments.
IVIG-SN racked up some 60 billion won ($49.77 million) in sales in Korea last year, according to Green Cross.
By Sohn Ji-young (
jys@heraldcorp.com)
