South Korean biopharma company Green Cross said Wednesday that the US Food and Drug Administration has completed its review of the firm’s immunodeficiency drug that was filed for approval in January.
Green Cross had submitted its biologics license application for IVIG-SN -- human normal immunoglobulin G for intravenous administration -- on Jan. 22.
After a yearlong review, the US FDA has asked Green Cross to submit additional data related to the drug’s production. The US drug regulator was satisfied on the drug’s efficacy and safety, the company said.
The Green Cross said it plans to submit the additional required documentation related to IVIG-SN’s production, after which the company will be closer to securing the agency’s final approval.
“We now have a clear road map to acquiring the US FDA’s approval (of the IVIG-SN). We plan to smoothly wrap up the remaining procedures, while also strengthening our marketing and sales strategy for the US market,” Green Cross CEO Huh Eun-chul said in a statement.
Exclusively developed by Green Cross, IVIG-SN treats primary immunodeficiency disorders which weaken or rid the immune system’s ability to fight infectious diseases.
The drug, which is already being sold in more than 30 countries in Asia, South America and the Middle East, is one of the Korean drugmaker’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)
