ADMA Biologics bought its contract manufacturer to make it happen, but the company has finally gotten permission to return its primary immune deficiency disease drug Bivigam to the market. The FDA approval comes seven years after the drug was first anointed and three years after it was pulled from the market.
The Ramsey, New Jersey-based company Friday said the FDA has signed off on its “optimized intravenous immune globulin manufacturing process” and approved its prior approval supplement for Bivigam so that it can again sell the drug. It anticipates relaunching the treatment in the second half of the year.
ADMA CEO Adam Grossman said the agency approval confirmed the extensive remediation and turnaround for its Boca Raton, Florida, manufacturing facility.
“We are pleased to reintroduce Bivigam into the market, where demand for IVIG therapy continues to outpace supply,” Grossman said in a statement. “The $6 billion U.S. 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.”
The approval follows a somewhat tortured effort for the company. The drug was first approved in 2012, but then issues with its manufacturing created concerns. A warning letter issued to its CDMO, Biotest Pharmaceuticals, followed in 2014. When the partners couldn’t get the issues quickly resolved, the product was pulled from the market in 2016.
The drugmaker then took an unusual course. It bought Biotest and began remediations at the plant. Last fall, it indicated that the FDA had upgraded the status of the facility and set a December date for the expected reapproval. But there was another setback: The FDA instead issued a complete response letter in December tied to lingering questions over ADMA's chemistry, manufacturing and controls processes.
The action on Bivigam comes just weeks after the FDA approved another of ADMA’s primary immune deficiency disease drugs. In April, it won an FDA nod for Asceniv, an intravenous immune globulin product for the treatment of primary humoral immunodeficiency disease in adults and adolescents 12 to 17 years of age.
Not only did it win the approval, but with it the company got the right to access up to $27.5 million from a credit facility with its backer Perceptive Advisors.