FDA Approves Yimmugo, an IVIG Product, to Treat Primary Immunodeficiencies

Biotest, a Grifols Group company, has received approval from the U.S. Food and Drug Administration (FDA) for Yimmugo (human — dira, 10% liquid), a newly developed polyvalent sugar-free intravenous immune globulin (IVIG) therapeutic, to treat primary immunodeficiencies (PI) in patients 2 years and older.

Approval was based on data from an open-label, prospective, Phase III study that evaluated the efficacy and safety of Yimmugo in 67 patients (mean age 35 years) with PI, who had established IVIG therapy for at least three months with a constant dose, and at least one IgG trough level of at least 5g/L during the previous three months.

Study participants received Yimmugo 0.2 to 0.8g/kg body weight at either every three or four weeks for 12 months. The primary endpoint was the rate of serious bacterial infections (SBI), defined as bacterial pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, visceral abscesses or bacterial meningitis over a period of 12 months.

The acute SBI rate was reported to be 0.07 during the 12-month study period, which met the predefined success rate of less than one acute SBI per patient per year. Five patients experienced an acute SBI (all five episodes were bacterial pneumonia). The most common adverse reactions observed with treatment were headache, upper respiratory tract infections, fatigue, nausea and increased blood pressure.

Yimmugo is supplied in a single-dose vial as a solution containing 10% immuoglobulin G (100mg/mL) in the following presentations: 5g in 50mL; 10g in 100mL; 20g in 200mL. The product was expected to be available in the second half of 2024.

Yimmugo is the first approved product from the new Biotest Next Level production facility. The modern production process stands for the highest product quality and an extremely responsible use of resources. “The addition of Biotest’s Yimmugo to our strong portfolio of intravenous and subcutaneous immunoglobulins provides another innovative treatment option for patients with primary immunodeficiencies who rely on these essential medicines in their daily lives,” said Roland Wandeler, president of Grifols Biopharma Business Unit.