Singapore, Feb. 21 -- CSL Behring K.K.has received manufacturing and marketing approval fromJapan'sMinistry of Health, Labour and Welfare (MHLW) for ANDEMBRY(garadacimab)Subcutaneous (SC) Injection 200mg Pens.
The product is approved for the prevention of acute attacks of hereditary angioedema (HAE) and is the first pre-filled pen presentation for once-monthly subcutaneous administration for long-term prophylaxis of HAE. The approval inJapanfollows additional recent approvals received inAustralia, theUnited Kingdom, and the European Union.
ANDEMBRYis the first fully human monoclonal antibody inJapandesigned to inhibit activated Factor XII (Factor XIIa), which initiates the cascade of events leading to angioedema at various sites of the ...
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