Delving into the Latest Updates on Immune Globulin Intravenous (Human) (Bio Products) with Synapse

Overview

Basic Info

Drug Type

Immunoglobulin

Synonyms

Immune globulin(Bio Products Laboratory), Subgam, Subgam-VF

+ [1]

Target-

Action

modulators

Mechanism

Immunomodulators

Therapeutic Areas

Immune System DiseasesCongenital DisordersHemic and Lymphatic Diseases+ [1]

Active Indication

Primary Immunodeficiency DiseasesPurpura, Thrombocytopenic, Idiopathic

Inactive Indication

Bruton Type AgammaglobulinemiaChronic idiopathic thrombocytopenic purpuraCommon Variable Immunodeficiency+ [3]

Originator Organization

Bio Products Laboratory USA, Inc.

Active Organization

Bio Products Laboratory USA, Inc.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

United States (17 Sep 2009),

Primary Immunodeficiency DiseasesPurpura, Thrombocytopenic, Idiopathic

Regulation-

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The primary objective is to demonstrate the bioequivalence of Gammaplex® 10 intravenous immunoglobulin (IGIV) and Gammaplex® 5% IGIV with respect to area under the curve within a 28-day dosing interval (AUC0-28) in a cohort of adult subjects.
The secondary objectives are to demonstrate the bioequivalence of Gammaplex® 10 IGIV and Gammaplex® 5% IGIV with respect to area under the curve within a 21-day dosing interval (AUC0-21) in adult subjects; to assess the pharmacokinetics of Gammaplex 10 IGIV and Gammaplex 5% IGIV including Immunoglobulin G (IgG) trough levels and to investigate the safety and tolerability of Gammaplex 10 IGIV and Gammaplex 5% IGIV in adults subjects; to assess the pharmacokinetics of Gammaplex 10 IGIV including IgG trough levels and to investigate the safety and tolerability of Gammaplex 10 IGIV in pediatric subjects.

Start Date01 Feb 2014

Sponsor / Collaborator

Bio Products Laboratory USA, Inc.

NCT02199925

/ Unknown statusPhase 4

A Phase IV, Single-site, Open-Label Study to Evaluate the Efficacy of High-Dose Gammaplex in Children on the Autism Spectrum

If autism is the consequence of a chronic inflammatory process preventing the infant brain from forming the proper neural connections, then treatment that reduces inflammation might have a positive impact on autism. IGIV treatment has been known to suppress inflammation and has been used in the treatment of inflammatory conditions and autoimmune diseases.

Start Date01 Jun 2013

Sponsor / Collaborator

IMMUNOe Health Centers

[+1]

100 Clinical Results associated with Immune Globulin Intravenous (Human) (Bio Products)

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100 Translational Medicine associated with Immune Globulin Intravenous (Human) (Bio Products)

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100 Patents (Medical) associated with Immune Globulin Intravenous (Human) (Bio Products)

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10

Literatures (Medical) associated with Immune Globulin Intravenous (Human) (Bio Products)

01 Nov 2019·Journal of Infusion Nursing

A Study of Tolerability, Satisfaction, and Cost Reduction Using a 10% Immunoglobulin Product at Higher Administration Rates

Article

Author: Chan, Sheryl ; Fadeyi, Michael ; Bauer, Susan

Gammaplex 10% (immune globulin intravenous [human], Bio Products Laboratory, Ltd) can be administered with a 15-minute rate-escalation protocol. This analysis examined safety, patient satisfaction, and cost savings in 49 patients administered Gammaplex 10% via rapid infusion over 11 months. Fourteen patients reported 38 adverse reactions, 37 of which were deemed minor/moderate. Patient satisfaction was very good/outstanding. Infusions were estimated to be 2.4 hours shorter than previously administered intravenous immunoglobulin infusions, saving $151.61 per visit in nursing costs. Rapid infusion of Gammaplex 10% was found to be a safe option to reduce the costs of intravenous immunoglobulin treatment while maintaining patient satisfaction.

01 Oct 2017·ImmunotherapyQ4 · MEDICINE

Gammaplex ^® 5 and 10% in the Treatment of Primary Immunodeficiency and Chronic Immune Thrombocytopenic Purpura

Q4 · MEDICINE

Review

Author: Wasserman, Richard L

Immunoglobulin G is used to both prevent infection in primary immunodeficiency diseases (PIDs) and prevent bleeding in immune thrombocytopenic purpura. Gammaplex is a highly purified human intravenous immunoglobulin G available as 5 and 10% liquid formulations. Gammaplex 5% has proven efficacy and safety in PID and immune thrombocytopenic purpura, protecting against serious acute bacterial infections and treating bleeding by improving platelet counts, respectively. The therapeutic effect of Gammaplex 10% is expected to be similar to that of Gammaplex 5% based on demonstrated bioequivalence in a bridging study in PID. The availability of Gammaplex 10% provides another option to individualize therapy according to patient needs, allowing a 34% reduction in infusion time without compromising safety and tolerability.

01 Aug 2017·Journal of Clinical Immunology

Erratum to: Evaluation of the Safety, Tolerability, and Pharmacokinetics of Gammaplex® 10% Versus Gammaplex® 5% in Subjects with Primary Immunodeficiency

Article

Author: Jolles, Stephen ; Norton, Miranda ; Wasserman, Richard L ; Stein, Mark R ; Moy, James N ; Melamed, Isaac R

The article was originally published Online First without open access.After publication in volume 37, issue 3, page 301-310 the author decided to opt for Open Choice and to make the article an open access publication.

1

News (Medical) associated with Immune Globulin Intravenous (Human) (Bio Products)

30 Mar 2023

·www.prnewswire.com

CSI Pharmacy Announces Limited Distribution Agreement for Gammaplex

NASH, Texas, March 30, 2023 /PRNewswire/ -- CSI Pharmacy, LLC, an independent, national specialty pharmacy and home infusion provider, today announced an agreement with Bio Products Laboratory (BPL) for limited distribution rights to its immune globulin product Gammaplex®. Access to Gammaplex means CSI Pharmacy is now able to dispense all FDA-approved immune globulin products. The company expects to begin stocking Gammaplex immediately. "Gammaplex not only expands our product portfolio, but it increases treatment options for patients who have various conditions," said COO Randy Broyles, RPh. "By diversifying our portfolio with BPL and other plasma product manufacturers, we're strengthening our industry partnerships, as well as strengthening the supply chain for our patients and customers." Immune globulin products contain human antibodies, derived primarily from donated human plasma. Multiple immune globulin products are manufactured for the U.S. market. They are commonly used to treat conditions such as primary and secondary immunodeficiencies, autoimmune neurological and dermatological disorders, as well as hundreds of other conditions believed to be immune mediated. "We want to thank BPL for trusting CSI to deliver a positive patient experience with its products," remarked co-founder and CEO James Sheets, PharmD. "As our company continues to grow, we will need partnerships like this one to secure product availability for customers, now and into the future." A CSI PHARMACY CSI Pharmacy is a national specialty pharmacy dedicated to serving patients with chronic and rare illnesses. Founded by pharmacists in 2014, the company specializes in treating rare diseases with biologics and plasma-derived therapies. It employs specially trained infusion nurses to provide these treatments to patients around the country. CSI continues to be led by co-founder and CEO, James Sheets, PharmD. Today, CSI Pharmacy is licensed to dispense in 48 states, plus D.C., and is accredited by two of the nation's leading specialty pharmacy accrediting bodies: the Accreditation Commission for Health Care (ACHC) and URAC. SOURCE CSI Pharmacy, LLC

License out/in

100 Deals associated with Immune Globulin Intravenous (Human) (Bio Products)

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Primary Immunodeficiency Diseases	United States	Bio Products Laboratory USA, Inc.	17 Sep 2009
Purpura, Thrombocytopenic, Idiopathic	United States	Bio Products Laboratory USA, Inc.	17 Sep 2009

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bruton Type Agammaglobulinemia	Phase 2	Hungary	Bio Products Laboratory USA, Inc.	01 Feb 2014
Bruton Type Agammaglobulinemia	Phase 2	United Kingdom	Bio Products Laboratory USA, Inc.	01 Feb 2014
Bruton Type Agammaglobulinemia	Phase 2	United States	Bio Products Laboratory USA, Inc.	01 Feb 2014
Chronic idiopathic thrombocytopenic purpura	Phase 2	India	Bio Products Laboratory USA, Inc.	01 Sep 2007
Chronic idiopathic thrombocytopenic purpura	Phase 2	Argentina	Bio Products Laboratory USA, Inc.	01 Sep 2007
Chronic idiopathic thrombocytopenic purpura	Phase 2	United States	Bio Products Laboratory USA, Inc.	01 Sep 2007
Common Variable Immunodeficiency	Phase 2	United States	Bio Products Laboratory USA, Inc.	01 Jan 2006
Hyper-IgM Immunodeficiency Syndrome	Phase 2	United States	Bio Products Laboratory USA, Inc.	01 Jan 2006
Hypogammaglobulinemia, X-Linked	Phase 2	United States	Bio Products Laboratory USA, Inc.	01 Jan 2006
Wiskott-Aldrich Syndrome	Phase 2	United States	Bio Products Laboratory USA, Inc.	01 Jan 2006

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01884311 (SCIG03, CTgov)	Phase 3	Common Variable Immunodeficiency \| Bruton Type Agammaglobulinemia \| Hyper-IgM Immunodeficiency Syndrome	38	Subgam	mzpajnqkmt(zciedjdpri) = zpvdnnnbtk koycifcstj (cmeislywtm, lrieowrtgp - fylqudtlpy) View more	-	12 Sep 2018
NCT01289847 (CTgov)	Phase 4	Common Variable Immunodeficiency \| Wiskott-Aldrich Syndrome \| Bruton Type Agammaglobulinemia \| Hyper-IgM Immunodeficiency Syndrome	25	Gammaplex	(audhwbbpsw) = klixzhbily dqhxemwqxi (jqdmlejicj, hmnhbrveji - znsyeproqd) View more	-	23 Dec 2014
NCT00504075 (CTgov)	Phase 3	Chronic idiopathic thrombocytopenic purpura	35	GAMMAPLEX	ogylgjnawe(hxvhbnjioi) = rnyjvmpxpm rvvtulsiqy (knknkqmiha, rkhnwnomjx - cxckxctxgl) View more	-	06 Jun 2012

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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