Kedrion Biopharma Launches YIMMUGO®: A New Treatment for Immunodeficiency

Kedrion Biopharma Introduces YIMMUGO® in the United States

Kedrion Biopharma is excited to announce that YIMMUGO (Immune Globulin Intravenous, Human-dira, 10%) is now available in the United States, reflecting the company’s dedication to making innovative treatments accessible for patients with primary immunodeficiency (PI). This launch signifies a major enhancement to their product line.

Innovative Immunoglobulin Therapy

YIMMUGO made its debut in Europe in 2022 and received approval from the U.S. Food and Drug Administration (FDA) on June 13, 2024. This modern 10% intravenous immunoglobulin (IVIG) is specifically designed for treating PI in patients aged 2 years and older. Developed by Biotest AG, which is part of the Grifols group, YIMMUGO represents a significant advancement in immunoglobulin therapy. In 2024, Kedrion Biopharma gained exclusive rights to distribute YIMMUGO in the United States.

The Importance of Primary Immunodeficiency Awareness

Primary immunodeficiency encompasses over 550 rare and chronic disorders that impair the immune system. Individuals suffering from PI often find themselves more prone to frequent infections and other serious health complications due to an inadequate immune response.

Current estimates indicate that about 500,000 individuals in the United States and roughly 6 million worldwide are living with PI. However, these numbers might not fully represent the reality, as many individuals go undiagnosed or are misdiagnosed, making an accurate understanding of the condition's prevalence difficult.

YIMMUGO: A Meaningful Treatment Option

In a growing market with rising demand for effective treatment solutions, YIMMUGO presents a valuable choice for patients. “We are enacting a patient-centered strategy to differentiate our Ig product line. Our experience and commitment empower us to provide impactful solutions to health care practitioners and patients in the IVIG market,” stated Bob Rossilli, Chief Commercial Officer and U.S. General Manager at Kedrion Biopharma.

YIMMUGO is accessible through a network of specialized pharmacies to ensure that patients can receive this critical treatment efficiently. CuraScript SD by Evernorth has been designated as the exclusive commercial distribution partner for YIMMUGO, facilitating streamlined access for both patients and healthcare providers.

Understanding YIMMUGO

YIMMUGO is a versatile immunoglobulin G preparation derived from human blood plasma, intended for intravenous use in patients aged 2 years and older who have primary humoral deficiency (PID). Remarkably, YIMMUGO is the inaugural product launched from the advanced Biotest Next Level production facility.

Safety Information

IMPORTANT SAFETY INFORMATION
Thrombosis, renal dysfunction, and acute renal failure are associated with immune globulin intravenous (IGIV) products like YIMMUGO. Ensure that patients who may be at risk receive the minimum effective dose and rate of infusion. Precautions should be taken to monitor hydration and blood viscosity, particularly in individuals with pre-existing health conditions.

YIMMUGO does not contain sucrose, a component that can increase the risk of renal dysfunction when using other IGIV products. It’s crucial for healthcare providers to monitor patients for any signs of complications during treatment.

About Kedrion Biopharma

Kedrion Biopharma specializes in collecting and processing blood plasma to create and distribute therapies for rare and debilitating conditions, such as coagulation disorders and immunodeficiencies. The company employs approximately 5,200 professionals around the world, operating 68 plasma collection centers in the United States and additional facilities across Europe. Kedrion is committed to partnering with the medical community and patient advocacy organizations to innovate and enhance patient care, making a tangible difference in many lives.

Frequently Asked Questions

What is YIMMUGO?

YIMMUGO is a 10% intravenous immunoglobulin therapy intended for treating primary immunodeficiency in patients aged 2 years and older.

Who is the manufacturer of YIMMUGO?

YIMMUGO is developed by Biotest AG, which is part of the Grifols group, and is marketed in the U.S. by Kedrion Biopharma.

Where can YIMMUGO be obtained?

YIMMUGO is available through a specialized distribution network, primarily at selected specialty pharmacies.

What are the risks associated with YIMMUGO?

YIMMUGO may pose risks of thrombosis, renal dysfunction, and acute renal failure, especially in predisposed patients. It is vital to monitor patients closely.

How does Kedrion Biopharma support patients with PI?

Kedrion Biopharma focuses on delivering therapies like YIMMUGO while collaborating with healthcare professionals to enhance patient outcomes through innovative approaches.

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