RI 002 filed with FDA for primary immune deficiency disease- ADMA Biologics

ADMA Biologics has submitted its Biologics License Application to the FDA, seeking marketing authorisation for RI 002 for treatment of patients diagnosed with primary immune deficiency disease (PIDD). RI 002 demonstrated positive results in a Phase III study in patients with PIDD, meeting its primary endpoint of no serious bacterial infections. These results, included in the submission, more than meet the requirement specified by the FDA guidance.

Polyclonal antibodies are proteins that are used by the body's immune system to neutralise microbes and are the primary active component of IGIV/immuneglobulin products. Data review indicates that the polyclonal antibodies present in RI-002 support its ability to prevent infections in immune-compromised patients. ADMA's analysis demonstrated that the Phase III trial met the primary endpoint with no serious bacterial infections reported.