CSL Launches ANDEMBRY® for Hereditary Angioedema Treatment in Japan

CSL has launched ANDEMBRY® Subcutaneous Injection 200 mg Pen (garadacimab) in Japan for the prevention of acute attacks in people with Hereditary Angioedema (HAE).

HAE is a rare and serious genetic condition that causes unpredictable and painful swelling episodes in various parts of the body, including the face, abdomen, limbs, and airway. It is listed in Japan as an intractable disease under ""Primary Immunodeficiency Syndrome."" Around 430 patients are currently diagnosed and receiving treatment in Japan. However, based on global prevalence data (1 in 50,000), the actual number of patients in Japan may be closer to 2,500.

ANDEMBRY® is a monoclonal antibody that targets FXIIa, the protein that starts the chain reaction causing swelling in HAE. By stopping this process early, ANDEMBRY® helps prevent attacks. It is now available as a once-monthly injection using a pre-filled pen, offering a new option for long-term prevention in people living with HAE.

ANDEMBRY® is a first-in-class human monoclonal antibody that blocks activated Factor XII (FXIIa), a protein involved in triggering swelling attacks. It is the first pre-filled pen approved for HAE in Japan, designed for once-monthly subcutaneous use, making it more convenient for patients.

The Ministry of Health, Labour and Welfare (MHLW) approved ANDEMBRY® on 20 February 2025. Approval was based on results from the global Phase III VANGUARD trial and its open-label extension, which included Japanese patients and showed the treatment to be both effective and safe.

The launch strengthens CSL’s portfolio in the HAE space, adding to its existing treatments, Berinert® IV and Berinert® SC. ANDEMBRY® is expected to help reduce the frequency of attacks, ease the burden of the condition, and improve quality of life for patients.

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