Marketing authorization in Japan for CSL's Berinert for HAE

28 September 2022

Japan’s Ministry of Health, Labor and Welfare (MHLW )has granted approval of the manufacturing and marketing application for Berinert SC Injection 2000 submitted by CSL Behring KK, a subsidiary of Australia’s CSL Limited (ASX: CSL).

The product is a lyophilized human C1-esterase inhibitor concentrate for subcutaneous (SC) injection in plasma derivative, f intended or the prevention of acute hereditary angioedema (HAE) attacks. Berinert SC Injection 2000 is a twice-weekly subcutaneous injection formulation of Berinert (esterase inhibitor [human]) 60 IU/kg that can be self-administered at home.

“This regulatory milestone underscores CSL’s ongoing promise and investment in the health and well-being of the people in Japan – and the value of these innovative treatments,” said Haruo Kitado, head of R&D Japan.

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