FDA Approves sBLA to Extend Temperature Storage Conditions for Two IVIG Products

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FDA approved the supplemental biologics license applications (sBLAs) for both intravenous immunoglobulin (IVIG), human – slra 10% liquid (IVIG slra, Asceniv; ADMA Biologics) and IVIG, human – 10% liquid (IVIG, Bivigam; ADMA Biologics) to extend the shelf life to 36 months. The IVIG therapies were previously approved for 4-week room temperature storage conditions of 25º Celsius during the first 24 months of shelf life. According to the FDA, the new room temperature approval will apply to all existing lots of the 2 IVIG therapies currently in the commercial supply chain in addition to future production.¹

Asceniv is plasma-derived and polyclonal and was approved by the FDA in April 2019 for the treatment of primary humoral immunodeficiency (PI), or primary immune deficiency disease, in adults and adolescents who are aged 12 to 17 years. The IVIG treatment contains naturally occurring polyclonal antibodies that are used by the body’s immune system to neutralize microbes to prevent infection and disease, such as bacteria.¹

According to the FDA, the initial approval was based on phase 3 clinical trial results that evaluated the safety and efficacy of Asceniv in 59 patients with PI, in which patients received regular infusions of the treatment for 12 months. The investigators noted there were no serious bacterial infections during the treatment period.²

Similarly to Asceniv, Bivigam is a plasma-derived, polyclonal IVIG that was approved in May 2019 for the treatment of PI. This includes, and is not limited to, genetic conditions such as X-linked and congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiency. Bivigam is a purified, sterile, and ready to use preparation of concentrated human immunoglobulin antibodies that help protect patients with PI from serious infections. It also has an approved sBLA for the treatment of pediatric patients aged 2 years and older who have PI.¹

The approval for pediatric patients came after a study that examined 16 children and adolescents with PI who received Bivigam, with doses ranging from 300 to 800 mg/kg every 3 to 4 weeks for approximately 5 months. The results indicated that 25% of patients experienced adverse events (AEs) that occurred during or within 72 hours after the end of infusion; however, reactions were mild to moderate in severity. Further, the investigators of this study noted that the established efficacy and safety were similar to the profiles for adult patients with PI.³

“With the FDA-approved extension of room temperature storage conditions, [we] expect to reach more customers who were previously inaccessible due to limited refrigeration space and cold chain capacity constraints,” said Adam Grossman, president and chief executive officer of ADMA Biologics, in a press release.¹

During the studies, commonly reported AEs for Asceniv included headache, sinusitis, diarrhea, gastroenteritis viral, nasopharyngitis, upper respiratory tract infection, bronchitis, and nausea, with AEs for Bivigam including headache, fatigue, infusion site reactions, nausea, sinusitis, increased blood pressure, diarrhea, dizziness, and lethargy in both pediatric and adult patients. Further, risk factors for those who take IVIG products include older age, prolonged immobilization, hypercoagulable conditions, a prior history of either venous or arterial thrombosis, among others.^2,3

“We believe that this added storage flexibility for both [IVIG therapies] will meaningfully enhance our products’ market offerings, enabling more versatile utilization and better inventory management for providers,” said Grossman in the press release.¹

References

1. BioSpace. ADMA Biologics Announces FDA Approvals of Extended Room Temperature Storage Conditions for ASCENIV™ & BIVIGAM®. News release. March 11, 2024. Accessed March 11, 2024. https://www.biospace.com/article/releases/adma-biologics-announces-fda-approvals-of-extended-room-temperature-storage-conditions-for-asceniv-and-bivigam-/

2. Novel Intravenous Immune Globulin Receives FDA Approval. Pharmacy Times. April 2, 2019. Accessed March 11, 2024. https://www.pharmacytimes.com/view/novel-intravenous-immune-globulin-receives-fda-approval

3. Gallagher, A. FDA Approves IVIG for Pediatric Patients Aged 2 and Older With Primary Humoral Immunodeficiency. Pharmacy Times. December 13, 2023. Accessed March 11, 2024. https://www.pharmacytimes.com/view/fda-approves-ivig-for-pediatric-patients-aged-2-and-older-with-primary-humoral-immunodeficiency