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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: 01 Apr 2019

At a glance

  • Drugs Immune globulin (Primary)
  • Indications Bacterial infections; Immunodeficiency disorders
  • Focus Registrational; Therapeutic Use
  • Sponsors ADMA Biologics
  • Most Recent Events

    • 01 Apr 2019 According to an ADMA Biologics media release, the U.S. Food and Drug Administration has approved ASCENIV, an Intravenous Immune Globulin, for the treatment of Primary Humoral Immunodeficiency Disease in adults and adolescents (12 to 17 years of age). The Company anticipates having the product available for commercial launch during the second half of 2019.
    • 17 Oct 2018 According to an ADMA Biologics media release, the U.S. Food and Drug Administration (FDA) has acknowledged the receipt of ADMAs September 28, 2018 BLA resubmission for RI-002 with an action due date of April 2, 2019, under the Prescription Drug User Fee Act (PDUFA).
    • 01 Oct 2018 According to an ADMA Biologics media release, the company has responded to the Complete Response Letter (CRL) and resubmitted its Biologics License Application (BLA) for RI-002 its product candidate to the U.S. Food and Drug Administration (FDA) on September 28, 2018. The Company was able to resubmit RI-002's BLA as a direct result of the recent improvement in compliance status for the Company's Boca Raton, FL manufacturing facility to Voluntary Action Indicated (VAI).
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