YIMMUGO® Launches in the U.S.: A New Treatment for Primary Immunodeficiency

Kedrion Biopharma Unveils YIMMUGO® in the U.S.

Kedrion Biopharma has officially launched its innovative treatment, YIMMUGO (Immune Globulin Intravenous, Human-dira, 10%), in the United States—a significant milestone that showcases the company’s commitment to improving access to vital therapies for individuals suffering from primary immunodeficiency (PI). This new therapy, approved by the U.S. Food and Drug Administration (FDA) on June 13, 2024, has been available in Europe since 2022 and promises to enhance the treatment landscape for patients aged two and older.

What is Primary Immunodeficiency?

Primary immunodeficiency encompasses a vast category of more than 550 rare, chronic conditions where the immune system is deficient. This dysfunction leaves patients more vulnerable to recurrent infections, autoimmune diseases, and other critical health challenges. An estimated 500,000 individuals in the United States live with PI, although true numbers might be significantly higher due to underdiagnosis or misdiagnosis of the disease.

The Significance of YIMMUGO®

YIMMUGO represents a breakthrough in immunoglobulin therapy, and its introduction is timely given the escalating demand for effective treatment options within the burgeoning PI market. According to Bob Rossilli, Chief Commercial Officer and U.S. General Manager at Kedrion Biopharma, the company’s robust and patient-focused strategy aims to expand and elevate its immunoglobulin (Ig) product offerings. He stated, “Our experience, agility, and unwavering dedication to patients and healthcare practitioners position us to make a substantial impact in the IVIG space.”

As the only product approved from the newly established Biotest Next Level production facility, YIMMUGO is a polyvalent IgG preparation derived from human plasma, designed specifically for intravenous administration. Its formulation is geared towards treating primary humoral deficiency (PID), reinforcing Kedrion's innovative approach in the healthcare sector.

Distribution and Access

Currently, YIMMUGO is accessible in the United States through an exclusive distribution network of specialty pharmacies. CuraScript SD by Evernorth is appointed as the sole commercial distribution partner, working to ensure that the therapy is readily available for patients and healthcare providers.

Important Safety Information

While YIMMUGO opens new doors for effective treatment, it’s essential to recognize the associated safety information. The therapy carries warnings regarding potential risks such as thrombosis and renal complications. Healthcare providers are advised to monitor patients closely, especially those who might be predisposed to these risks, and to administer the product at the minimum effective dosage.

The Commitment of Kedrion Biopharma

Kedrion Biopharma is dedicated to producing and distributing plasma-derived therapies for various conditions, including immunodeficiencies and coagulation disorders. The company's global workforce and extensive infrastructure—including 68 plasma collection centers in the U.S. and multiple production facilities worldwide—underscore its commitment to advancing medical innovation and improving patient care. As they forge partnerships with medical institutions and patient advocacy groups, Kedrion Biopharma continually strives to enhance the treatment experiences and outcomes for those in need.

In conclusion, the launch of YIMMUGO marks a pivotal moment in the landscape of immunotherapy for patients with primary immunodeficiency. By addressing a crucial unmet need, Kedrion Biopharma is on track to make a meaningful difference in the lives of many.

For comprehensive information regarding YIMMUGO, including safety information and dosage guidelines, please visit the Kedrion Biopharma website.