CANBERA (dpa-AFX) - CSL Limited (CSL.AX) Thursday, announced that the European Commission has approved ANDEMBRY, a once-monthly treatment for hereditary angioedema or HAE in patients aged 12 and older.
ANDEMBRY prevents HAE attacks with a convenient auto-injector for self-administration.
ANDEMBRY, garadacimab, is a new monoclonal antibody that blocks Factor XIIa. It has completed Phase 3 trials as a once-monthly injection to prevent HAE attacks, a type of swelling caused by bradykinin.
The approval follows data from the Phase 3 VANGUARD trial. CSL Behring will launch ANDEMBRY after access and reimbursement negotiations. It is also under review in the U.S., Japan, Switzerland, and Canada.
Developed at CSL's Bio21 research site and manufactured at CSL Broadmeadows, ANDEMBRY marks CSL's first fully developed recombinant monoclonal antibody. It has received approvals in Australia and the UK. Potential side effects include injection site reactions.
CSL.AX closed Wednesday's trading at 254.00 Australian dollars, down 0.89 percent on the Australian Stock Exchange.
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