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Drugs / Immunoglobulin Intravenous (Human)
last change Feb 2020 re-read 3 minutes ago

Immunoglobulin Intravenous (Human)

also known as Privigen

Protein / enzyme biologic

Developed for
autoimmune thrombocytopenic purpura
Investigated by
CSL Behring

Trials 1

today NCT00168038 · Ph 3
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 3 NCT00168038 Dec 2004 → Feb 2006 autoimmune thrombocytopenic purpura CSL Behring Completed No outcome recorded

Press releases naming this drug 11 releases

DateIssuerRelease
2020-02-11 CSL Behring PRIVIGEN® (Immune Globulin Intravenous (Human), 10% Liquid) Granted Orphan-Drug Designation for the Investigational Treatment of Systemic Sclerosis (SSc) csl.com ↗
2017-09-14 CSL Behring CSL Behring Announces FDA Approval of Privigen® [Immune Globulin Intravenous (Human), 10% Liquid] for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in Adults csl.com ↗
2017-02-14 CSL Behring FDA Accepts CSL Behring’s Biologics License Application Supplement for Using Privigen® to Treat Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a Rare Neurological Condition csl.com ↗
2016-02-24 CSL Behring CSL Behring Adds Isoagglutinin Reduction Step to Privigen® Manufacturing Process csl.com ↗
2016-02-23 CSL Behring First Export of Privigen® From New Manufacturing Facility in Broadmeadows, Melbourne, Australia csl.com ↗
2013-04-04 CSL Behring European Commission Grants Marketing Authorization to CSL Behring’s Privigen® in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) csl.com ↗
2013-02-21 CSL Behring CSL Behring Announces New Vial Size of Privigen® for Treatment of Primary Immunodeficiency and Chronic Immune Thrombocytopenic Purpura csl.com ↗
2012-06-27 CSL Behring PRIMA Study Shows Treatment with Privigen® Improved Function in Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) csl.com ↗
2012-05-31 CSL Behring CSL Behring Submits Marketing Authorization Variation Application to European Medicines Agency (EMA) for Privigen® in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) csl.com ↗
2010-10-07 CSL Behring Privigen Demonstrates Efficacy and Tolerability Among Patients With Various Immunodeficiencies, Data Show csl.com ↗
2010-04-19 CSL Behring CSL Behring Receives FDA Approval to Extend Shelf Life for Privigen® from 24 to 36 Months csl.com ↗

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as Immunoglobulin Intravenous (Human) ClinicalTrials.gov intervention name — accepted as the source's own label NCT00168038 ↗
Known as Privigen “Privigen” NCT00168038 ↗
Modality Protein / enzyme biologic “Privigen, a new, ready-to-use, 10% liquid human IgG formulation” PMID 19635187 ↗ Aug 2009
Route Intravenous “Efficacy and safety of Privigen, a novel liquid intravenous immunoglobulin formulation, in adolescent and adult patients with chronic immune thrombocytopenic purpura.” PMID 19635187 ↗ Aug 2009