An Open Label, Multicenter, Study to Evaluate the Pharmacokinetics, Efficacy and Safety of RI-002 (IGIV) in Subjects With Primary Immunodeficiency Diseases (PIDD)

Trial Profile

An Open Label, Multicenter, Study to Evaluate the Pharmacokinetics, Efficacy and Safety of RI-002 (IGIV) in Subjects With Primary Immunodeficiency Diseases (PIDD)

Completed
Phase of Trial: Phase III

Latest Information Update: 13 Oct 2016

At a glance

  • Drugs RI 002 (Primary)
  • Indications Immunodeficiency disorders; Respiratory syncytial virus infections
  • Focus Registrational; Therapeutic Use
  • Sponsors ADMA Biologics
  • Most Recent Events

    • 29 Jul 2016 According to an ADMA Biologics media release, the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to the Company's Biologics License Application (BLA) for RI-002, an Intravenous Immune Globulin (IVIG), for the treatment of patients with Primary Humoral Immunodeficiency Disease (PIDD).
    • 21 Sep 2015 According to an ADMA Biologics media release, on 18 September 2015, the U.S. FDA accepted for review the Company's Biologics License Application (BLA) for RI-002 intended for the primary immunodeficiency (PI) population. The Prescription Drug User Fee Act (PDUFA) date to complete the review has been scheduled for the second half of 2016.
    • 07 Apr 2015 According to ADMA Biologics media release, data from this trial will be presented at the upcoming Clinical Immunology Society 2015 Annual Meeting.
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