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PR Newswire is an important news source that can be accessed via the X-Billboard. It is part of the Newswire Hub, which bundles important international news sources for stock market participants in one central location. If you want to get a quick overview, you can easily scroll through the headlines. If you want to look at the news in more detail, you can use the detailed views of the info cards to directly access the respective news item and other analysis tools.
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State: 17.08.2024 | 11PM
Fri, 13.12.2024       CSL Seqirus
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If approved, garadacimab will be the first and only once-monthly treatment inhibiting factor XIIa to prevent attacks in HAE patients – a community CSL has been serving for more than 40 years

MARBURG, Germany, Dec. 13, 2024 /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) today announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending granting a marketing authorization for garadacimab as a once-monthly prophylactic treatment for hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older. Garadacimab is a monoclonal antibody that targets activated factor XII (factor XIIa), a plasma protein that plays a key role in attacks of swelling in people with HAE, thereby inhibiting the HAE cascade at the top to prevent HAE attacks. The final European Commission (EC) decision is expected in Q1 2025.

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