FDA okays GC Biopharma’s Alyglo for primary immunodeficiency

2023-12-18

上市批准临床3期临床结果免疫疗法

GC Biopharma announced the FDA approval of Alyglo (immune globulin intravenous, human-stwk) 10% liquid for the treatment of adults aged 17 and above with primary humoral immunodeficiency (PI). The clearance comes nearly a month ahead of the agency’s target review date of January 13, 2024.

CEO Eun-chul Huh said Alyglo's approval marks a “significant milestone for GC Biopharma and patients with PI disease,” and reflects the company’s globally growing rare disease portfolio. The drugmaker also highlighted the use of cation exchange chromatography in Alyglo’s manufacturing to reduce coagulation factor XIa to undetectable levels, mitigating any potential risk of thromboembolic events.

The approval was based on the findings from a Phase III study conducted in the US and Canada, which hit its primary endpoint of 0.03 acute serious bacterial infections (aSBIs) per patient-year, meeting the FDA efficacy requirement of the rate of adverse events linked to infusions within 72 hours was 0.22, fulfilling the FDA requirement of less than 0.40.

GC Biopharma had filed Alyglo's application with the FDA in 2021, but received a complete response letter in February last year. Following a delayed pre-license inspection of its manufacturing facility in Ochang, Korea earlier this year, the application was resubmitted to the FDA in July.

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