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news.The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to the ADMA Biologics' Biologics License Application (BLA) for RI-002, an Intravenous Immune Globulin (IVIG), for the treatment of patients with Primary Humoral Immunodeficiency Disease (PIDD).
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The CRL did not cite any concerns with the clinical safety and efficacy data for RI-002 submitted by ADMA in the BLA, nor has the FDA requested any additional clinical studies be conducted prior to FDA approval of RI-002 for PIDD.
The FDA identified in the CRL certain outstanding inspection issues and deficiencies at ADMA’s third-party contract manufacturers, including its contract drug substance and product manufacturer, its contract fill and finisher and compliance issues with a third-party contract testing laboratory, and requested documentation of corrections for a number of those issues.
ADMA has been informed by its third party drug substance and product manufacturer that it is working to resolve the outstanding inspection issues.
ADMA will work diligently with the Company’s third party drug substance and product manufacturer, its contract fill and finish provider and a third-party contract testing laboratory to monitor their efforts in addressing and resolving outstanding issues relating to the observations.
The Company will work with the agency to reach an agreement on acceptable language for the package insert and container and vial labeling, if and when approval is granted.
ADMA Biologics president and CEO Adam Grossman said: “ADMA is highly committed to bring RI-002 to market, offering another IVIG treatment option for the heterogeneous population of immune deficient patients.
“We will continue to collaborate as effectively and expeditiously as possible with our third-party contract manufacturers and testing laboratory to resolve the outstanding deficiencies. We continue to build our commercial organization and infrastructure in preparation for the earliest possible launch of our product.”