FDA

Qivigy OK’d for primary humoral immunodeficiency in adults

October 2, 2025

FDA has approved Qivigy (immune globulin IV, human-kthm) 10% solution for the treatment of adults with primary humoral immunodeficiency (PI).

Efficacy

Efficacy was evaluated in the open-label, prospective CARES10 study involving adult patients with primary humoral immunodeficiency (NCT03961009). A total of 47 patients received IV infusion of Qivigy at a dose of 266 to 826 mg/kg every 3 (n=8) or 4 weeks (n=39) for 12 months.

The primary efficacy outcome was the incidence rate of acute serious bacterial infections (SBIs; bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscess, and osteomyelitis/septic arthritis). Secondary efficacy outcomes included the incidence rate of infections other than acute SBIs, patients hospitalized due to infection, number and duration of antibiotic treatment for any kind of infection, and missed work/school/other major activities due to infections.

No acute SBIs were reported during the trial. Results for secondary outcomes were as follows:

• Annualized rate of other infections (not including acute SBIs): 2.1 infections per patient year
• Patients hospitalized due to infection: 0
• Duration of antibiotic treatment for any kind of infection: 10 days (range, 1-334)
• Missed work/school/other major activities due to infections: 6 days (range, 1-53)

Safety

The most common adverse reactions (≥5%) were headache, fatigue, nausea, infusion-related reaction, positive Coombs direct test, sinusitis, dizziness, and diarrhea.

Sources:

Qivigy (immune globulin IV, human-kthm) [package insert]. Food and Drug Administration. https://www.fda.gov/media/188981/download Revised September 2025. Accessed October 1, 2025.

Kedrion Biopharma receives FDA approval for Qivigy® (immune globulin 10% IV) for treatment of primary humoral immunodeficiency in adults and confirms its plan to increase investments in the US throughout its global operations. [News release]. 2025. https://www.kedrion.com/kedrion-biopharma-receives-fda-approval-for-qivigy-and-confirms-its-plan-to-increase-investments-in-the-us-throughout-its-global-operations/