Health Canada Approves CSL's ANDEMBRY for Hereditary Angioedema Treatment

Health Canada has authorized CSL's ANDEMBRY (garadacimab) as a once-monthly treatment for hereditary angioedema (HAE). ANDEMBRY is the first and only once-monthly treatment targeting factor XIIa to prevent recurrent attacks in people with HAE. The authorization expands CSL's HAE franchise and underscores the company's commitment to delivering innovative medicines to the HAE community.

Health Canada has granted marketing authorization for CSL's ANDEMBRY (garadacimab) as a once-monthly treatment for hereditary angioedema (HAE). This authorization represents a significant advancement in the treatment of HAE, which is a rare, chronic, and potentially life-threatening genetic disorder [1].

ANDEMBRY is the first and only once-monthly treatment targeting factor XIIa (FXIIa) to prevent recurrent attacks in people with HAE. The authorization expands CSL's HAE franchise and underscores the company's commitment to delivering innovative medicines to the HAE community [1].

The Health Canada authorization is based on data from the pivotal placebo-controlled Phase 3 VANGUARD trial, which demonstrated that treatment with ANDEMBRY reduced HAE attacks by a median of more than 99 percent and a reduced least squares mean of 89.2 percent compared to placebo. The trial also showed that 62 percent of ANDEMBRY-treated patients remained attack-free throughout the treatment period [1].

The most common adverse reactions in the pivotal trial were injection site erythema, injection site bruising, injection site pruritus, injection site urticaria, headache, and abdominal pain. A published interim analysis of the ongoing open-label extension study showed that ANDEMBRY has a favorable long-term safety profile and provides sustained reductions in HAE attacks [1].

The authorization of ANDEMBRY is another crucial step in building toward the global availability of the treatment, which has already been approved in Australia, the United Kingdom, the European Union, Japan, Switzerland, and the United States [1].

About CSL
CSL (ASX:CSL; USOTC:CSLLY) is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat Hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. The company's unique combination of commercial strength, R&D focus, and operational excellence enables it to identify, develop, and deliver innovations so patients can live life to the fullest [2].

References:
[1] https://finance.yahoo.com/news/health-canada-authorized-csls-andembry-120000111.html
[2] https://www.csl.com/