GC said it has submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) for Alyglo, its 10 percent intravenous immunoglobulin.

Alyglo, sold under the brand name IVIG-SN 10 percent in Korea, is a liquid immunoglobulin preparation purified from plasma fractions.

Korean hospitals use the drug to treat primary immunodeficiency diseases such as congenital immunodeficiency syndrome and immune thrombocytopenia.

According to the company, the FDA conducted a pre-license inspection of the Ochang blood product manufacturing facility in April, which was delayed due to the Covid-19 pandemic last year. The company completed the BLA submission last Friday after consultation with the FDA.

GC had previously reported that it had received a notice of delay in product approval for Alyglo through a complete response letter (CRL) from the FDA in February of last year. CRL is a supplementary request letter sent by the FDA to a company requiring additional measures after comprehensively reviewing the drug application for approval.

During that time, a company official stressed that the only reason for the delayed approval was the failure to conduct a pre-license inspection of the company's Ochang blood product production facility within the FDA target review period.

"We are aiming to receive approval early next year and launch the product in the U.S. market in the second half of the year," a GC official said.

Meanwhile, according to the Marketing Research Bureau, a market research firm, the U.S. immunoglobulin market was estimated to be worth about $12.5 trillion in 2021, and the demand for immunoglobulins is continuously increasing due to the recent increase in autoimmune diseases.