CSL Limited (CSL.AX), Thursday announced that it has received manufacturing and marketing approval from Japan's Ministry of Health, Labour and Welfare for Andembry Subcutaneous Injection 200mg Pens for the prevention of acute attacks of hereditary angioedema.
The approval is based on the efficacy and safety data from the pivotal international Phase 3 VANGUARD trial and its open-label extension study.
Recently, additional approvals were received in Australia, the United Kingdom, and the European Union for the same product.
CSL's stock closed at AUD 258.89, down 2.25 percent on the ASX.
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