FDA Approves IVIG for Pediatric Patients Aged 2 and Older With Primary Humoral Immunodeficiency

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Bivigam was initially approved by the FDA in May 2019 for the treatment of primary humoral immunodeficiency, including a group of genetic disorders.

The FDA has approved a supplemental biologics license application (sBLA) for immune globulin intravenous (IVIG) (Bivigam; ADMA Biologics Inc) for use in pediatric patients aged 2 years and older with primary humoral immunodeficiency (PI). The sBLA was submitted under section 351(a) of the Public Health Service Act.¹

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"We are pleased to announce that [IVIG] has received FDA approval for treating PI in patients aged 2 years and older. Previously, the indication for [IVIG] was restricted to PI patients aged 12 years and older,” Adam Grossman, president and CEO of ADMA, said in a press release. “This expanded label for [IVIG] allows ADMA to actively address the treatment needs of younger PI patients earlier in their treatment journey. In the periods ahead, we look forward to offering [IVIG] as an FDA-approved treatment option for these pediatric PI patients.”¹

IVIG is plasma-derived and polyclonal, which was initially approved by the FDA in May 2019 for the treatment of PI, including a group of genetic disorders. This could include X-linked and congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiency, according to the press release.¹

According to the prescribing information, the pediatric-only study was a prospective, open-label, multi-center trial with 16 children and adolescents with PI who received IVIG, ranging from 300 to 800 mg/kg every 3 weeks or 4 weeks, for approximately 5 months. All individuals were male and 80% were White. The study showed that 25% of individuals experienced adverse reactions, occurring during or within 72 hours after end of infusion. Reactions were mild or moderate in severity, with no infusion site reactions in the study. For the pediatric study, reactions included fatigue, headache, nausea, and rash.²

The efficacy analysis was based on the incidence of serious bacterial infections (SBIs), including bacteremia or sepsis, bacterial meningitis, osteomyelitis or septic arthritis, bacterial pneumonia, or visceral abscess. There were no SBIs in the cohort during the mean observation period (152 days), according to the prescribing information. There were no other serious infection or hospitalizations due to infection in the study. Further, no individuals in the study needed intravenous antibiotics during the study.²

Additionally, investigators reported that the trough total immunoglobulin G (IgG) levels were maintained above 500 mg/dL in all individuals throughout the study, with no apparent difference in total IgG before the first and last infusion.²

In the study, the safety and efficacy were established based on the findings, demonstrating the effects were similar to those in adults. There were no specific dose requirements necessary to achieve the targeted IgG levels for pediatrics.²

The drug is purified in a ready-to-use sterile preparations and contains antibodies directed against bacteria and viruses to help protect individuals with PI. IVIG products can cause thrombosis, renal dysfunction, and acute renal failure. Risk factors include advanced age, prolonged immobilization, hypercoagulable conditions, a history of venous or arterial thrombosis, and more, according to the press release. IVIG is contraindicated for those with a history of anaphylactic or severe systemic reactions to human immunoglobulin and those who are immunoglobulin A deficient with a history of hypersensitivity.¹

Commonly reported reactions for all individuals, including adults, included headache, fatigue, infusion site reaction, nausea, sinusitis, increased blood pressure, diarrhea, dizziness, and lethargy, according to the press release.¹

Reference

ADMA Biologics announces FDA approval for Bivigam in the pediatric patient setting for those 2 years of age and older. News release. Adam Biologics. December 12, 2023. Accessed December 13, 2023. https://ir.admabiologics.com/news-releases/news-release-details/adma-biologics-announces-fda-approval-bivigamr-pediatric-patient
Bivigam: prescribing information. ADMA Biologics. 2012. Revised 2023. https://www.fda.gov/media/84782/download