Haemostasis March 2025 News

Our round-up of the latest developments from across the haemostasis industry for March 2025.

REGULATORY

• Genentech’s TNKase (tenecteplase, tissue plasminogen activator) was approved by the FDA for the treatment of acute ischemic stroke (AIS) in adults, administered as a single 5-second intravenous (IV) bolus (3 Mar)
• Sanofi / Alnylam’s Qfitlia (fitusiran, antithrombin RNAi) was approved by the FDA for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and paediatric patients 12 years of age and older with haemophilia A or haemophilia B, with or without factor VIII or IX inhibitors (28 Mar)
• Siemens Healthineers’ INNOVANCE Antithrombin (AT) assay was cleared by the FDA as a companion diagnostic for Sanofi / Alnylam’s Qfitlia to measure AT levels. Through the Qfitlia Testing Program with Labcorp, the FDA-cleared companion diagnostic will be available to patients prescribed Qfitlia to measure AT levels at no cost (28 Mar)

CLINICAL

• Anthos Therapeutics presented two new analyses from  AZALEA-TIMI 71 Ph2b trial at the ACC 2025 demonstrating that abelacimab (Factor XI mAb) significantly reduced bleeding in patients regardless of age or bleeding risk (31 Mar)
• SERB Pharmaceuticals and SFJ Pharmaceuticals announced that REVERSE-IT Ph3 trial evaluating bentracimab (a human Fab targeting ticagrelor and its active metabolites) met primary endpoint, demonstrating significant, rapid restoration of platelet function in both patients requiring urgent surgery and  those with major bleeding (31 Mar)

COMMERCIAL

• Kedrion Biopharma expanded the distribution network for Ryplazim (a plasma-derived human plasminogen), the only FDA approved therapy indicated for treating patients with plasminogen deficiency type 1 (PLGD-1) (21 Mar)