"Global biotechnology leader CSL announced today that the Swiss Agency for Therapeutic Products (Swissmedic) has granted marketing authorization to ANDEMBRY® (garadacimab) for long-term prophylaxis of recurring attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. ANDEMBRY®, a monoclonal antibody, inhibits plasma protein factor XIIa, which initiates the cascade of events leading to angioedema at various sites of the body.
“This approval from Swissmedic marks the fifth regulatory approval of ANDEMBRY® for HAE, following recent approvals in Australia, the UK, the EU, and Japan,” said Emmanuelle Lecomte-Brisset, Global Head of Regulatory Affairs at CSL. “We are incredibly proud of these milestones, which reflect our decades-long commitment to delivering innovative medicines to the HAE community. Access and reimbursement negotiations are currently underway to ensure that ANDEMBRY® is made available to eligible people with HAE in Switzerland.”
“With the approval of ANDEMBRY®, following Berinert® IV (intravenous) and Berinert® SC (subcutaneous), CSL Behring now offers an even more comprehensive portfolio for the management of HAE,” said Dr. Isabelle Dahinden, General Manager Switzerland, CSL Behring. “This allows us to meet the diverse needs of people living with HAE, a community we have supported for more than 40 years.”
“While there are current treatments available for HAE, individual needs and responses to treatment vary,” said Dr. Michael Haslauer, Country Medical Lead Switzerland, CSL Behring. “ANDEMBRY® offers people living with HAE a vital new treatment option that provides long-term control over their disease.”
About Hereditary Angioedema (HAE)
HAE is a rare, chronic, debilitating, and potentially life-threatening genetic disorder characterized by recurrent and unpredictable attacks of angioedema. Attacks of HAE are often painful and can spread to multiple sites of the body, including the abdomen, larynx, face, and extremities. HAE occurs in about 1 in 50,000 people of any ethnic group.
About ANDEMBRY® (garadacimab)
ANDEMBRY® (garadacimab) is a novel Factor XIIa-inhibitory monoclonal antibody (anti-FXIIa mAb) that has completed Phase 3 clinical development as a new type of once-monthly subcutaneous long-term prophylactic treatment for attacks related to HAE, a form of bradykinin-mediated angioedema. ANDEMBRY® is CSL's first homegrown recombinant monoclonal antibody to gain approval. It was discovered and optimized by scientists at CSL's Bio21-based research site, with formulation and manufacturing for the clinical programs completed at the CSL Broadmeadows Biotech Manufacturing Facility. ANDEMBRY® uniquely inhibits the plasma protein, FXIIa. When FXII is activated, it initiates the cascade of events leading to edema formation. By targeting FXIIa, ANDEMBRY® inhibits this cascade at the initiating event rather than downstream mediators.
The Swissmedic approval of ANDEMBRY® is based on efficacy and safety data from the pivotal international Phase 3 VANGUARD trial and its open-label extension study. The detailed results of the VANGUARD trial were published in The Lancet in April 2023 and the primary results of the ongoing open-label extension study were published in Allergy (October 2024).
The most commonly observed side effects associated with ANDEMBRY® in the phase 3 clinical trial were injection site reactions (2/39, 5.1%) including redness, bruising and itchiness.
About CSL
CSL (ASX:CSL; USOTC:CSLLY) is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses: CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest.