• 13 Mar 2024
• Admin
• News Article

ADMA Biologics Gains Approval Storage Conditions for Asceniv & Bivigam

ADMA Biologics receives US FDA approvals of extended room temperature storage conditions for Asceniv & Bivigam

ADMA Biologics, Inc., an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics, announced the United States Food and Drug Administration’s (FDA) approval for its supplemental Biologics License Applications (BLAs) for both Asceniv and Bivigam to extend the approved 4-week room temperature (25°C) storage conditions during the first 24 months of shelf life, to allow for a 4-week room temperature storage at any time during the entire 36-month approved shelf life.

Approval for:- 

The room temperature approval applies to all existing Asceniv and Bivigam lots currently in the commercial supply chain as well as to future production of Asceniv and Bivigam.

Words from CEO: ADMA

“With the FDA-approved extension of room temperature storage conditions, the company expects 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. “We believe that this added storage flexibility for both Asceniv and Bivigam will meaningfully enhance our products’ market offerings, enabling more versatile utilization and better inventory management for providers.”

Effects

The newly approved extension of room temperature storage conditions for both Asceniv and Bivigam is immediately effective, and both products are commercially available to US healthcare providers and patients.

About Asceniv

• Asceniv (immune globulin intravenous, human – slra 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG). Asceniv was approved by the United States Food and Drug Administration (FDA) in April 2019 and is indicated for the treatment of primary humoral immunodeficiency (PI), also known as primary immune deficiency disease (PIDD), in adults and adolescents (12 to 17 years of age). 
• Asceniv is manufactured using ADMA’s unique, patented plasma donor screening methodology and tailored plasma pooling design, which blends normal source plasma and respiratory syncytial virus (RSV) plasma obtained from donors tested using the company’s proprietary microneutralization assay. 
• Asceniv contains naturally occurring polyclonal antibodies, which are proteins that are used by the body’s immune system to neutralize microbes, such as bacteria and viruses and prevent against infection and disease. 
• Asceniv is protected by US Patents: 9,107,906, 9,714,283 and 9,815,886.

About Bivigam

• Bivigam (immune globulin intravenous, human – 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG). 
• Bivigam was approved by the FDA in MAY 2019 and is indicated for the treatment of primary humoral immunodeficiency (PI), including, but not limited to, the following group of genetic disorders: X-linked and congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome and severe combined immunodeficiency. Bivigam contains a broad range of antibodies similar to those found in normal human plasma. 
• These antibodies are directed against bacteria and viruses and help to protect PI patients against serious infections. 
• Bivigam is a purified, sterile, ready-to-use preparation of concentrated human Immunoglobulin antibodies.

About ADMA Biologics

ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases.