FDA OKs Relaunch of Novel Intravenous Immune Globulin Product
The FDA approved a Prior Approval Supplement for immune globulin intravenous (human), 10% liquid (Bivigam, ADMA Biologics) for patients with primary humoral immunodeficiency disease.
Officials with the FDA have approved ADMA Biologics’ Prior Approval Supplement (PAS) for immune globulin intravenous (human), 10% liquid (Bivigam), previously known as RI-002, according to a press release.
The novel intravenous immune globulin (IVIG) product is indicated for individuals with primary humoral immunodeficiency disease (PIDD), which includes X-linked and congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiency.
The FDA previously approved the IVIG therapy in December 2012, but certain manufacturing and compliance issues led to voluntary suspension of commercial production in 2016. The PAS approval permits the use of the ADMA’s optimized IVIG manufacturing process, allowing the company to commence sales of the product.
The IVIG product was designed to reduce the frequency of serious bacterial infections (SBIs) in patients with PIDD. Its initial approval was based on a phase 3 clinical trial in which the drug was administered as an intravenous infusion every 21 or 28 days in approximately 60 patients with PIDD. According to the data, the trial met its primary endpoint with zero SBIs.
PIDD, a class of inherited genetic disorders, causes affected individuals to have a deficient or absent immune system, which makes them vulnerable to infections and related complications. These patients typically receive monthly treatment with polyclonal immune globulin products to protect them from persistent and chronic infections, according to ADMA.
“We are pleased to re-introduce Bivigam into the market, where demand for IVIG therapy continues to outpace supply,” Adam Grossman, president and chief executive officer of ADMA, said in a statement. “The $6 billion US market for IVIG continues to grow and the relaunch of Bivigam can help to alleviate a portion of the tight supply for this important patient population, where dependable and consistent supply of IVIG is critical to patients’ well-being.”
ADMA anticipates the re-launch of immune globulin intravenous (human), 10% liquid for commercial sale during the second half of 2019, according to the release.
ADMA announces it will commence commercial sales of Bivigam [news release]. ADMA Biologics. https://www.admabiologics.com/news/detail/439/fda-approves-prior-approval-supplement-for-bivigam. Accessed May 13, 2019.
ADMA Biologics announces positive data on primary and secondary endpoint from its pivotal phase 3 clinical trial for RI-002 at the AAAAI Medical Conference [news release]. ADMA. https://www.admabiologics.com/news/detail/304/adma-biologics-announces-positive-data-on-primary-and. Accessed May 13, 2019.