GC Pharma gets CRL from US FDA for Alyglo

South Korea’s GC Pharma (KRX:006280) saw its shares fall 6.2% to 182,000 won, after it revealed it has received a Complete Response Letter (CRL) from the US Food and Drug Administration in response to its Biologics License Application (BLA) for Alyglo (immune globulin intravenous (human), 10% liquid).

The FDA issues a CRL to indicate that the review cycle for an application is complete but the application cannot be approved in its current form.

The FDA recommended a pre-license inspection of GC Pharma’s Ochang facility in order to support approval of the company’s application. GC Pharma, formerly known as Green Cross Corporation, conducted a Remote Interactive Evaluations by the FDA in fourth-quarter 2021 due to restrictions on travel related to the COVID-19 pandemic.