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ADMA Biologics, Inc. announces the commercial relaunch and its first commercial sales of Bivigam for primary humoral immunodeficiency

Read time: 1 mins
Last updated:27th Aug 2019
Published:25th Aug 2019
Source: Pharmawand

ADMA Biologics, Inc. a vertically integrated commercial biopharmaceutical and specialty immunoglobulin company that manufactures and markets three approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases, announces the commercial relaunch and its first commercial sales of Bivigam.

As previously reported, Bivigam had a Biologics License Application (“BLA”) manufacturing change Prior Approval Supplement (“PAS”) approved by the FDA on 9 May 2019, enabling ADMA to resume marketing Bivigam to US- based prescribers and healthcare professionals. Bivigam is approved for the treatment of patients diagnosed with primary humoral immunodeficiency (“PI”). This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency (“CVID”), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Initially thought to be very rare, it is now believed that as many as 250,000 people in the U.S. have some form of Primary Humoral Immunodeficiency (“PI”). 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 (“IgG”) antibodies. Antibodies are proteins in the human immune system that work to defend against infections and disease.

FDA’s initial approval for Bivigam was received by BPC ( Biotest Pharmaceutical Company) in December 2012, and production of Bivigam was halted by BPC in December 2016. ADMA obtained ownership and all rights, title and interest in Bivigam in June 2017 as part of the Biotest Therapy Business Unit (“BTBU”) acquisition in June 2017 and resumed the production of Bivigam during the fourth quarter of 2017. Based on ADMA’s optimized IVIG manufacturing process, the FDA approved a Prior Approval Supplement to amend the Biologics License Application for the product on 9 May, 2019, allowing the Company to resume supplying Bivigam to the U.S. market. The FDA completed the license transfer for Bivigam to ADMA on July 2, 2019. Bivigam was reintroduced to the US market on 22 August 2019.

Bivigam will be available through BioCare SD, the authorized distributor. Prescribers and healthcare professionals interested in purchasing Bivigam for use with their PI patients should contact BioCare SD directly at 800-304-3064 or by visiting their website at www.BioCareSD.com.

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