GC Biopharma Unveils ALYGLO™ for Immunodeficiency Treatment

GC Biopharma Launches ALYGLO™ for Immune Treatment

GC Biopharma USA, Inc. has exciting news about its groundbreaking immunoglobulin product, ALYGLO (immune globulin intravenous, human-stwk). This innovative therapy is now available in the marketplace for adult patients aged 17 years and older suffering from primary humoral immunodeficiency (PI). This condition is quite rare and chronic, reflecting a significant challenge as the body's ability to produce antibodies is compromised, leading to increased vulnerability to infections.

The Significance of ALYGLO for Patients

For individuals with PI, ALYGLO represents a vital treatment option. This disorder impairs the immune defenses, accentuating the need for effective therapies. ALYGLO has impressively met primary safety and efficacy endpoints as mandated by the FDA in rigorous Phase 3 clinical trials. A noteworthy aspect of ALYGLO is its sophisticated manufacturing process, incorporating Cation Exchange Chromatography (CEX) to remove coagulation factor XIa (FXIa) to levels that are undetectable. The medication received FDA approval on Dec. 15, 2023.

Dr. Eun Chul Huh’s Vision

Dr. Eun Chul Huh, President and CEO of GC Biopharma, emphasizes the launch's importance, describing it as a historic milestone. "The US launch of ALYGLO exemplifies our commitment to enhancing the health and lives of individuals facing rare diseases globally," he stated. This initiative showcases GC Biopharma's mission of investing in research and development to curate several future products that will positively impact the US healthcare landscape.

Accessible Distribution Network for Patients

ALYGLO will be accessible to both patients and healthcare professionals via a carefully selected limited distribution network of premier national Specialty Pharmacy providers. This strategy guarantees a wide-reaching availability, which is essential for those diagnosed with primary immune deficiencies. Additionally, ALYGLO can also be sourced through specialty distributors across the United States.

Statement from Dr. Lisa Betts

Dr. Lisa Betts, the Chief Operating Officer for GC Biopharma USA, Inc., expressed her enthusiasm: "ALYGLO significantly expands treatment options, enhancing access in the US marketplace. Our goal is to provide life-saving therapies to individuals with rare diseases, and we are thrilled to introduce another immune globulin therapeutic alternative for patients."

Understanding Primary Humoral Immunodeficiency (PI)

Primary Humoral Immunodeficiency (PI) encompasses various disorders characterized by the body's inability to produce adequate antibodies. This incapacity leads to increased vulnerability to infections, particularly bacterial ones affecting respiratory and gastrointestinal systems. The conditions treated by ALYGLO include congenital agammaglobulinemia, common variable immunodeficiency (CVID), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies—all illustrating the crucial need for effective treatment options.

About ALYGLO

ALYGLO offers a 10% solution of immunoglobulin G intended for intravenous infusion, sourced from pooled human plasma. The thorough production process includes critical steps to mitigate the risk of virus transmission, such as fractionation, solvent/detergent treatment, and nanofiltration. The use of advanced CEX technology during manufacturing ensures the removal of FXIa, further enhancing safety.

About GC Biopharma Corp.

With a legacy spanning over half a century, GC Biopharma Corp. (previously known as Green Cross Corporation) stands as a biopharmaceutical trailblazer, delivering vital protein therapeutics and vaccines. Headquartered in Yongin, South Korea, GC Biopharma dedicates itself to facilitating quality healthcare solutions on a global scale.

About GC Biopharma USA, Inc.

Founded in 2018 in Teaneck, NJ, GC Biopharma USA, Inc. specializes in sales, marketing, and business strategies to serve patients and healthcare providers across the US. Backed by the substantial expertise of its parent company, GC Biopharma USA aims to broaden its influence and provide world-class plasma therapies and vaccines.

Frequently Asked Questions

What is ALYGLO used for?

ALYGLO is utilized for treating primary humoral immunodeficiency in adults, enhancing the body’s ability to combat infections.

How is ALYGLO manufactured?

ALYGLO is produced using advanced processes including Cation Exchange Chromatography to ensure safety and efficacy.

Who can prescribe ALYGLO?

ALYGLO can be prescribed by qualified healthcare professionals to adult patients diagnosed with primary humoral immunodeficiency.

What safety information should I know about ALYGLO?

Important safety information includes potential allergic reactions and the need for monitoring during infusion. Patients should discuss any concerns with their healthcare provider.

How can patients obtain ALYGLO?

Patients can acquire ALYGLO through a limited distribution network of national Specialty Pharmacy partners and specialty distributors in the United States.

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