CSL Behring’s angioedema treatments receives NICE recommendation
Charlie Blackie-Kelly | September 26, 2025 | News story | Regulatory Affairs, Research and Development | Andembry, CSL Behring, hereditary angioedema
The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending CSL Behring’s ANDEMBRY (garadacimab) for the treatment of hereditary angioedema (HAE).
HAE is a rare and chronic genetic condition characterised by recurrent and unpredictable angioedema attacks, leading to painful swelling in various parts of the body. The disease affects approximately one in 50,000 people in the UK and can significantly impair quality of life and daily functioning.
ANDEMBRY is a first-in-class monoclonal antibody (mAb) administered via a pre-filled pen. It works by inhibiting the plasma protein factor XIIa, a key driver of oedema events. Under the guidance, patients aged 12 years and older who experience two or more attacks per month will be eligible to access once-monthly prophylactic treatment.
The recommendation is supported by data from the phase 3 VANGUARD study and its open-label extension, which demonstrated that ANDEMBRY significantly reduced both the frequency and severity of HAE attacks.
“We are delighted that NICE has recognised the value of ANDEMBRY and the importance of expanding access to preventive treatment options for a broad range of eligible people living with HAE,” commented Eduardo Cabas, general manager, CSL Behring UK & Ireland. “This recommendation reflects our commitment to delivering innovative therapies that address unmet needs and may improve the lives of patients with rare diseases.”
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