CLINICAL TRIALS PROFILE FOR GAMMAGARD LIQUID

All Clinical Trials for GAMMAGARD LIQUID

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02123615 ↗	ASIS for GAMMAGARD in Primary Immunodeficiency	Unknown status	ASIS Corporation	Phase 1/Phase 2	2016-01-01	ASIS Corporation (ASIS) has developed the only automatic injection system for delivery of injectable products to it's optimum/right spot, just outside of the fascia, which exists subdermally (between the skin and muscle). Bloodless basically implies longer lasting medicinal effects, and minimal side effects - advantages that reflect the NIH mission of enhancing health, lengthening life, and reducing the burdens of illness and disability. ASIS device is stabilized on the surface of the skin with negative pressure and emits an electrical current to create a bloodless cavity subdermally. ASIS device correctly, automatically, and consistently delivers therapeutic agents, yet requiring little skill of a practitioner - providing the steady and safe infusion into subdermal bloodless space of virtually any injectable product in addition to Botox, including GAMMAGARD LIQUID, Enbrel, Insulin, and Fillers, etc. According to the FDA, "This innovation will have major impact on the healthcare industry."
NCT01736579 ↗	Long-Term Study of IGIV, 10% in Alzheimer´s Disease	Terminated	Baxalta now part of Shire	Phase 3	2012-11-29	The purpose of this long-term study is to provide additional evidence of safety and efficacy of IGIV, 10% treatment in participants with Alzheimer´s Disease who have completed the Phase 3 Baxter precursor study 160701. All participants will receive IGIV, 10% at either 0.2 g/kg or 0.4 g/kg body weight depending on their treatment assignment in Baxter study 160701. Participants and investigators will be blinded to dose unless otherwise notified by the sponsor.
NCT01736579 ↗	Long-Term Study of IGIV, 10% in Alzheimer´s Disease	Terminated	Baxalta US Inc.	Phase 3	2012-11-29	The purpose of this long-term study is to provide additional evidence of safety and efficacy of IGIV, 10% treatment in participants with Alzheimer´s Disease who have completed the Phase 3 Baxter precursor study 160701. All participants will receive IGIV, 10% at either 0.2 g/kg or 0.4 g/kg body weight depending on their treatment assignment in Baxter study 160701. Participants and investigators will be blinded to dose unless otherwise notified by the sponsor.

Clinical Trial Conditions for GAMMAGARD LIQUID

Condition Name

Condition Name for GAMMAGARD LIQUID
Intervention	Trials
Alzheimer´s Disease	1
Primary Immunodeficiency	1

Condition MeSH

Condition MeSH for GAMMAGARD LIQUID
Intervention	Trials
Immunologic Deficiency Syndromes	1
Alzheimer Disease	1
Primary Immunodeficiency Diseases	1

Clinical Trial Locations for GAMMAGARD LIQUID

Trials by Country

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−

Trials by Country for GAMMAGARD LIQUID
Location	Trials
United States	2

Trials by US State

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−

Trials by US State for GAMMAGARD LIQUID
Location	Trials
California	1
New York	1

Clinical Trial Progress for GAMMAGARD LIQUID

Clinical Trial Phase

Clinical Trial Phase for GAMMAGARD LIQUID
Clinical Trial Phase	Trials
Phase 3	1
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for GAMMAGARD LIQUID
Clinical Trial Phase	Trials
Terminated	1
Unknown status	1

Clinical Trial Sponsors for GAMMAGARD LIQUID

Sponsor Name

Sponsor Name for GAMMAGARD LIQUID
Sponsor	Trials
Baxalta now part of Shire	1
Baxalta US Inc.	1
ASIS Corporation	1

Sponsor Type

Sponsor Type for GAMMAGARD LIQUID
Sponsor	Trials
Industry	3

GAMMAGARD LIQUID: Clinical Trials, Market Analysis, and Projections

Introduction to GAMMAGARD LIQUID

GAMMAGARD LIQUID, an intravenous and subcutaneous immunoglobulin (IG) preparation, has been extensively studied and approved for various indications, including primary immunodeficiency (PI) and chronic inflammatory demyelinating polyneuropathy (CIDP). Here, we delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials for Primary Immunodeficiency (PI)

Sustained Efficacy with Intravenous Immune Globulin (IVIG) Treatment

In a phase 3, multicenter clinical trial involving 61 patients with PI, GAMMAGARD LIQUID demonstrated significant efficacy when administered intravenously. Key findings include:

• Zero validated acute serious bacterial infections (ASBIs): This rate was significantly lower than the FDA-set threshold of less than 1 per patient per year[1].
• Zero hospitalizations secondary to validated bacterial infections: This highlights the drug's effectiveness in preventing severe infections.
• Low rate of other bacterial infections: Only four validated other bacterial infections were reported, including urinary tract infection, gastroenteritis, and otitis media[1].

Sustained Efficacy with Subcutaneous IG (SCIG) Treatment

A prospective, open-label, non-controlled, multicenter study of 47 patients with PI evaluated the efficacy of GAMMAGARD LIQUID when administered subcutaneously. The results showed:

• Annual rate of ASBIs: 0.067 per patient per year, which is significantly lower than the FDA-set threshold[1].
• Zero infection-related hospitalizations: No hospitalizations due to infections were reported.
• Minimal impact on daily activities: Patients experienced only four days of missed work or school or days unable to perform normal activities per patient per year[1].

Clinical Trials for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

FDA Approval and Clinical Trial Data

The FDA approved GAMMAGARD LIQUID for the treatment of adults with CIDP based on data from the phase 3 ADVANCE-CIDP 2 clinical trial. This trial was a prospective, open-label, single-arm, multicenter study.

• Responder Rate: A significant 94.4% of participants demonstrated improvement in functional disability, indicating a substantial therapeutic benefit[4][5].
• Dosing and Administration: Participants received an induction dose of 2g/kg body weight followed by maintenance doses every three weeks for six months. The study showed improvements in grip strength and Rasch-built Overall Disability Scale score change[4][5].

Market Analysis

Global Immunoglobulin Market

The global immunoglobulin market, which includes products like GAMMAGARD LIQUID, is projected to grow significantly. Here are some key market insights:

• Market Size: The global immunoglobulin market was valued at USD 16.24 billion in 2023 and is expected to grow to USD 35.85 billion by 2032[2].
• Regional Growth: Asia Pacific is anticipated to grow with the highest CAGR due to rising healthcare reforms, government initiatives, and increasing healthcare expenditure. Latin America and the Middle East & Africa are also expected to see moderate growth[2].
• Market Consolidation: The market is dominated by a few major players, including Grifols, S.A., CSL Limited, and Takeda Pharmaceutical Company Limited[2].

Market Projections

Increasing Demand and Adoption

Several factors are driving the growth of the immunoglobulin market, including:

• Rising Patient Population: The increasing number of patients suffering from immunodeficiencies and other conditions treatable with immunoglobulins is a key driver[2].
• Reimbursement and Accessibility: Government initiatives to provide costly IG therapies at an affordable cost and increasing reimbursement for these drugs are expected to boost consumption[2].
• Product Awareness and Availability: Growing product awareness and the increasing availability of these therapies in various regions will further drive demand[2].

Competitive Landscape

Key Players

The immunoglobulin market is highly competitive, with a few major players holding a significant market share. Takeda Pharmaceutical Company Limited, the manufacturer of GAMMAGARD LIQUID, is one of these key players. The competitive landscape is influenced by factors such as product efficacy, safety, pricing, and market penetration[2][3].

Sales Forecasts

Historical and Future Sales Performance

Historical sales data and forecasts indicate that GAMMAGARD LIQUID has strong sales potential. For instance, detailed clinical assessments and sales forecasts have been provided in reports that analyze the drug's performance in various markets, including the US and EU5[3].

Conclusion

GAMMAGARD LIQUID has demonstrated robust efficacy in clinical trials for both PI and CIDP, positioning it as a valuable treatment option. The global immunoglobulin market is expected to grow significantly, driven by increasing demand, government initiatives, and rising healthcare expenditure. As one of the leading products in this market, GAMMAGARD LIQUID is poised for continued success.

Key Takeaways

• Clinical Efficacy: GAMMAGARD LIQUID has shown sustained efficacy in preventing infections in PI patients and improving functional disability in CIDP patients.
• Market Growth: The global immunoglobulin market is projected to grow from USD 17.58 billion in 2024 to USD 35.85 billion by 2032.
• Regional Expansion: Asia Pacific, Latin America, and the Middle East & Africa are expected to see significant growth due to various market drivers.
• Competitive Landscape: The market is dominated by a few major players, with Takeda Pharmaceutical Company Limited being a key player.

FAQs

What are the primary indications for GAMMAGARD LIQUID?

GAMMAGARD LIQUID is primarily indicated for the treatment of primary immunodeficiency (PI) and chronic inflammatory demyelinating polyneuropathy (CIDP).

What were the key findings of the clinical trials for PI?

The clinical trials for PI showed zero validated acute serious bacterial infections (ASBIs) and zero infection-related hospitalizations when GAMMAGARD LIQUID was administered intravenously, and a low annual rate of ASBIs when administered subcutaneously[1].

What is the responder rate in the ADVANCE-CIDP 2 clinical trial for CIDP?

The responder rate in the ADVANCE-CIDP 2 clinical trial was 94.4%, indicating significant improvement in functional disability among participants[4][5].

How is the global immunoglobulin market expected to grow?

The global immunoglobulin market is projected to grow from USD 17.58 billion in 2024 to USD 35.85 billion by 2032, with Asia Pacific expected to grow with the highest CAGR[2].

Who are the major players in the immunoglobulin market?

The major players in the immunoglobulin market include Grifols, S.A., CSL Limited, and Takeda Pharmaceutical Company Limited[2].

Sources

1. GAMMAGARD LIQUID Clinical Trials: Primary Immunodeficiency (PI) - GAMMAGARD LIQUID Clinical Trials.
2. Immunoglobulin Market Size, Share & Global Report [2032] - Fortune Business Insights.
3. Research and Markets: Gammagard Liquid (Alzheimer's disease) - Business Wire.
4. FDA approves Takeda's GAMMAGARD LIQUID for CIDP treatment - Pharmaceutical Technology.
5. Gammagard Liquid Receives FDA Approval to Treat Disability and Impairment Associated with Chronic Inflammatory Demyelinating Polyneuropathy - Practical Neurology.