RI 002

Drug Profile

RI 002

Alternative Names: IGIV - ADMA Biologics; Immune globulin intravenous - ADMA Biologics; Respiratory syncytial virus immune globulin - ADMA Biologics; RI-001; RI-002

Latest Information Update: 01 Aug 2016

Price : $50

At a glance

  • Originator ADMA Biologics; Baylor College of Medicine
  • Developer ADMA Biologics
  • Class Antivirals; Immunoglobulins; Immunoproteins; Serum globulins
  • Mechanism of Action Immunostimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity No

Highest Development Phases

  • Preregistration Immunodeficiency disorders

Most Recent Events

  • 29 Jul 2016 ADMA Biologics receives complete response letter from the FDA for RI 002 in Immunodeficiency disorders
  • 07 Mar 2016 Pharmacodynamics data from a preclinical studies in Immunodeficiency disorders presented at the American Academy of Allergy Asthma & Immunology (AAAAI -2016)
  • 03 Nov 2015 Additional pharmacodynamics data from a preclinical trial in Immunodeficiency disorders released by ADMA Biologics
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