GC Pharma wins FDA approval for ALYGLO

[Courtesy of GC Biopharma]

South Korea’s GC Pharma announced on Monday that it has obtained approval from the U.S. Food and Drug Administration (FDA) for its ALYGLO, an intravenous immunoglobulin product, on December 15th, 2023 (local time).

GC Pharma will launch ALYGLO in the United States in the second half of 2024 via its U.S. subsidiary, GC Biopharma USA. ALYGLO is one of GC Pharma’s flagship blood products for primary immunodeficiencies.

GC Pharma previously submitted a Biologics License Application (BLA) for ALYGLO to the FDA in 2021. However, the FDA postponed its on-site inspection of the company’s blood product manufacturing facility in Korea due to the Covid-19 pandemic, leading to a deferral decision in February 2022.

The FDA finally conducted its on-site inspection of GC Pharma’s Osong facility in April 2023 and the company resubmitted the BLA in July.

The recent approval, attained earlier than the FDA’s stipulated approval deadline of January 13, 2024, came around a month ahead of schedule, according to the company.

The U.S. immunoglobulin market stood at about $10.4 billion based on 2022’s figures. With the uptick in autoimmune diseases due to an aging population, the demand for immunoglobulin products within the United States is growing, the company said.