CSL Behring KK has gained approval from Japan's Ministry of Health, Labour and Welfare (MHLW) to manufacture and market subcutaneous (SC) injection 200mg Andembry pens designed to prevent acute attacks of hereditary angioedema (HAE).
It is the first pre-filled pen presentation of Andembry, intended for once-monthly SC administration for the disease’s long-term prophylaxis.
The MHLW's decision is underpinned by the safety and efficacy data from the international Phase III VANGUARD trial and its open-label extension.
The latest approval follows authorisations in the European Union, Australia and the UK.
CSL research and development for Japan and China regional lead and executive director Dr Rose Fida stated:"Andembry is a breakthrough therapy as the first and only treatment targeting activated Factor XII, the key initiator of HAE attacks.
"With its novel mechanism, once-monthly subcutaneous dosing and easy-to-use pre-filled pen, Andembry is set to transform the way HAE is managed in Japan."
Andembry is the first fully human monoclonal antibody in the country that targets activated Factor XII (Factor XIIa), a key initiator in the cascade of events leading to angioedema.
By blocking FXIIa, the therapy interrupts the oedema-forming process at its inception.
As a prophylactic treatment for HAE-related attacks, the therapy has completed a Phase III clinical development.
Andembry's development involved CSL's Bio21-based research site scientists, with the clinical programme's formulation and manufacturing completed at the CSL Broadmeadows biotech manufacturing facility.
HAE is a life-threatening condition marked by recurrent angioedema attacks in parts of the body including the larynx, face, extremities and abdomen.
It is classified under Japan's "primary immunodeficiency syndrome" as one of the intractable conditions.
CSL Behring KK is a part of the Australian biotechnology company, CSL.
In November 2023, Japan’s MHLW approved CSL and Arcturus Therapeutics’ self-amplifying mRNA (sa-mRNA) Covid-19 vaccine, ARCT-154.
