FDA Approves CSL’s Andembry: A New Era in Hereditary Angioedema Prevention
FDA's Innovative Move in HAE Treatment
In a monumental step for hereditary angioedema management, the FDA has approved CSL’s Andembry (garadacimab-gxii). This first-in-class, once-monthly subcutaneous (SC) treatment offers a novel approach to preventing HAE attacks for patients aged 12 years and older. By specifically targeting factor XIIa, Andembry inhibits the inflammatory cascade associated with HAE.
Self-Administration and Efficacy
- Andembry can be self-administered in under 15 seconds via autoinjector.
- This approval is based on pivotal results from the Phase III VANGUARD trial.
- Andembry represents CSL’s first fully discovered and developed monoclonal antibody.
How Does Andembry Change HAE Management?
This cutting-edge therapy is poised to revolutionize hereditary angioedema prophylaxis, offering patients an effective solution to minimize their attack frequency and improve overall quality of life.
This article was prepared using information from open sources in accordance with the principles of Ethical Policy. The editorial team is not responsible for absolute accuracy, as it relies on data from the sources referenced.