CSL Behring’s New Monoclonal Antibody Treatment ANDEMBRY® Receives Approval in Japan
CSL Behring K.K., a leading global biotherapeutics company, recently made a significant breakthrough in the treatment of Hereditary Angioedema (HAE). The company announced that it has received manufacturing and marketing approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for ANDEMBRY® (garadacimab) Subcutaneous (S.C.).
What is ANDEMBRY®?
ANDEMBRY® is a first-in-class monoclonal antibody treatment that inhibits activated Factor XII (FXIIa), the initiating factor in the HAE pathway. This new treatment offers a major advancement as it is the first pre-filled pen presentation enabling once-monthly subcutaneous administration.
Background and Clinical Trials
The approval is based on the results of the international pivotal Phase 3 VANGUARD trial. This trial included HAE patients from Japan, and the data demonstrated the safety and efficacy of ANDEMBRY® in preventing HAE attacks. CSL Behring has been dedicated to improving the lives of those with HAE for over 40 years, and this approval marks another step forward in fulfilling their mission.
Impact on Individuals with HAE
For individuals with HAE, this approval signifies a new hope for more convenient and effective treatment. ANDEMBRY®’s once-monthly administration offers a significant improvement over the current standard of twice-weekly injections or on-demand treatments. This not only reduces the burden on patients but also offers better control over their condition.
Impact on the World
Beyond Japan, ANDEMBRY® has already received approval in the European Union, the United States, and other countries. This approval in Japan further solidifies its position as a leading treatment for HAE. With its convenient dosing schedule and proven efficacy, ANDEMBRY® is expected to change the way HAE is managed, providing better quality of life for patients around the world.
CSL Behring’s Commitment to the HAE Community
CSL Behring has a long-standing commitment to the HAE community. Their dedication to improving the lives of those with HAE has been evident for over 40 years. With the approval of ANDEMBRY®, they continue to make strides in addressing the unmet needs of this patient population.
Conclusion
The approval of ANDEMBRY® in Japan marks an important milestone in the treatment of HAE. With its once-monthly administration and proven efficacy, this monoclonal antibody treatment offers a significant improvement over current treatment options. CSL Behring’s commitment to the HAE community remains strong, and this approval further solidifies their position as a leader in the field.
- ANDEMBRY® is a first-in-class monoclonal antibody treatment for HAE that inhibits activated Factor XII (FXIIa)
- Once-monthly subcutaneous administration
- Approval based on international pivotal Phase 3 VANGUARD trial results
- CSL Behring has a long-standing commitment to the HAE community, having supported it for over 40 years
- Expected to change the way HAE is managed, providing better quality of life for patients around the world
