CSL Receives Approval in Japan for ANDEMBRY® (garadacimab) Subcutaneous (S.C.) Injection 200mg Pens, a Novel Human Anti-Activated Factor XII Monoclonal Antibody for the Prevention of Acute Attacks of Hereditary Angioedema (HAE)
Portfolio Pulse from
CSL Behring has received approval in Japan for ANDEMBRY® (garadacimab) subcutaneous injection pens, a novel treatment for hereditary angioedema (HAE). This approval is based on the Phase 3 VANGUARD trial and marks a significant advancement in HAE treatment.

February 20, 2025 | 2:30 pm
News sentiment analysis
Sort by:
Ascending
POSITIVE IMPACT
CSL Behring's ANDEMBRY® has been approved in Japan for treating hereditary angioedema, marking a significant milestone in the company's product offerings and potentially boosting its market presence in Japan.
The approval of ANDEMBRY® in Japan represents a significant regulatory milestone for CSL Behring, potentially increasing its market share and revenue in the Japanese market. The product's novel delivery method and its status as a first-in-class treatment could drive adoption among HAE patients.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100