CSL has announced that the Swiss Agency for Therapeutic Products (Swissmedic) has approved Andembry (garadacimab) for the long-term prophylaxis of recurring attacks of hereditary angioedema (HAE).
This approval applies to both adult and paediatric patients aged 12 years and older.
Andembry is a monoclonal antibody that targets the plasma protein factor XIIa. It is designed to initiate the cascade of events leading to angioedema in the body.
The latest approval marks the fifth regulatory clearance for the drug. Andembry received multiple regulatory approvals in early 2025.
Australia’s Therapeutic Goods Administration (TGA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted authorisation for the product last month.
Recently, the European Commission (EC) and Japan’s Ministry of Health, Labour and Welfare (MHLW) also approved the HAE therapy.
Swissmedic granted approval for garadacimab based on data from the Phase 3 VANGUARD trial and its open-label extension study.
The VANGUARD trial results were published in April 2023, while the open-label study’s primary results were published in October 2024.
The most common side effects in the Phase 3 trial were mild injection site reactions (5.1%), including redness, bruising, and itchiness.
CSL regulatory affairs global head Emmanuelle Lecomte-Brisset said: “This approval from Swissmedic marks the fifth regulatory approval of Andembry for HAE, following recent approvals in Australia, the UK, the EU, and Japan.
“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 Andembryis made available to eligible people with HAE in Switzerland.”
Andembry has been developed for the long-term prophylactic treatment of hereditary angioedema.
It offers a once-monthly subcutaneous injection option for preventing HAE attacks.
Garadacimab is said to be CSL’s first internally developed recombinant monoclonal antibody to receive approval. It was discovered and optimised by CSL scientists at the Bio21 research site, with formulation and manufacturing carried out at the CSL Broadmeadows Biotech Manufacturing Facility.
