FDA Approves 10% IVIG Formulation For Adults With Primary Humoral Immunodeficiency

The FDA has approved intravenous immunoglobulin (IVIG) [human]-kthm 10% liquid (Qivigy; Kedrion Biopharma) for the treatment of adults with primary humoral immunodeficiency (PI), according to a news release from Kedrion Biopharma.

With a new formulation of IVIG now available, patients with PI and other immunodeficiencies have more options than ever to address their unmet needs and reduce the impact of their condition on their daily lives.¹

What is Primary Immunodeficiency?

PIs comprise a group of over 500 chronic conditions characterized by a portion of the body’s immune system not working correctly or being missing. The conditions primary feature an inability for the body to effectively fight infections. Thus, infections can be difficult to clear, continue to return, or unusually severe. PI can also lead to other symptoms, including vasculitis and autoimmune symptoms.^1,2

Around 500,000 individuals in the United States live with PI. However, the Immune Deficiency Foundation explains that, when considering all variations and types of PI, as much as 2% of the US population may be impacted.

With a significant burden to thousands and perhaps millions of patients, the sustained development of new therapies to attempt to reduce the incidence of severe infections is paramount. Qivigy provides a diverse population of patients with a new medication to combat the condition and gives pharmacists another tool in their counseling arsenal for patient visits and education.¹

New IVIG Formulation is Safe and Effective at Reducing Infection Incidence

Qivigy’s efficacy and safety was assessed in a clinical trial, CARES10 (NCT03961009). Forty-seven adults were enrolled in the open-label, prospective study, receiving intravenous infusions of the immunoglobulins at a dose of 266-to-826 mg/kg every 3 or 4 weeks for 12 months. Furthermore, 39 and 8 patients were infused with Qivigy on a 4-week or 3-week infusion cycle, respectively.^1,3

Study investigators primarily sought to elucidate the incidence of acute serious bacterial infections (SBIs), such as bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscess, and osteomyelitis/septic arthritis. Additionally, they aimed to evaluate the incidence of non-SBIs, including patients hospitalized due to infection, the number and duration of antibiotic treatment for any infection, and reports of missed school, work, or other major activities because of infections.¹

In meeting the study’s primary end point, Qivigy ensured 0 acute SBIs over the 12-month trial period. The annualized rate of other non-SBI infections was 2.1 infections per patient per year, while 0 patients with PI were hospitalized because of an infection during the study period. Regarding safety, the most common product-related adverse events reported across the population—observed in less than 5% of patients—were headache, fatigue, nauseua, infusion-related reaction, and a direct Coombs positive test, which detects antibodies that may destroy red blood cells.¹

Importantly, the study’s secondary outcomes were also met. Patients reported a low rate of other infections and minimal disruptions to their daily activities. Allowing patients to return to their normal routines is a key aspect of restoring individual physical and mental health, and with a new IVIG formulation now available, more patients will have access to life-changing medication. Pharmacists, especially those operating in specialty centers or infusion clinics, must educate and familiarize themselves on the new product and be ready to counsel patients with PI on the benefits and possible complications of treatment.¹

“For individuals living with primary immunodeficiency, the absence of serious bacterial infections means fewer disruptions to daily life which in turn means less time away from school and work due to hospitalizations,” Nisha Jain, vice president, global clinical development, Kedrion Biopharma, said in the news release.¹

REFERENCES

1. Kedrion Biopharma. 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 U.S. throughout its global operations. News Release. Released September 29, 2025. Accessed September 29, 2025. https://www.kedrion.us/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-u-s-t/

2. Understanding primary immunodeficiency—What is PI? Immune Deficiency Foundation. Accessed September 29, 2025. https://primaryimmune.org/understanding-primary-immunodeficiency/what-is-pi

3. Clinical assessment of pharmacokinetics, efficacy, and safety of 10% IVIg in PID patients (CARES10). ClinicalTrials.gov Identifier: NCT03961009. Last Updated April 13, 2025. Accessed September 29, 2025. https://clinicaltrials.gov/study/NCT03961009