Haemostasis October 2024 Industry News
Our monthly round-up of the latest developments from across the haemostasis industry for October 2024.
REGULATORY
- Pfizer’s Hympavzi (marstacimab-hncq, TFPI mAb) approved by the FDA for routine prophylaxis to prevent or reduce bleeding episodes in adults and adolescents 12+ with haemophilia A or B without inhibitors; making it the first subcutaneous non-factor once weekly haemophilia B treatment (11 Oct)
- Novo Nordisk’s Alhemo (concizumab, TFPI mAb) recommended for European approval as the first once-daily subcutaneous prophylactic treatment for people aged 12 or older with haemophilia A or B with inhibitors (18 Oct)
- Grifols’ Vistaseal (FS, plasma-protein based fibrin sealant) received FDA approval for treatment of surgical bleeding in paediatric patients. Vistaseal, commercialised by Johnson & Johnson, combines fibrinogen and thrombin and is applied using airless spray technology (29 Oct)
CLINICAL
- Inari Medical partnered with the American Venous Forum (AVF) and the National Blood Clot Alliance (NBCA) on the DEFIANCE trial to compare clinical outcomes in patients with deep vein thrombosis (DVT) treated with Inari’s ClotTriever System vs. anticoagulation alone (15 Oct)
- HemoSonics awarded prize from the NIH to expand use of Quantra Hemostasis System to improve the management of peripartum bleeding in obstetric patients (21 Oct)
- HELP-PCI trial data, presented at TCT2024, showed that pretreatment with a loading dose of unfractionated heparin at first medical contact improves spontaneous reperfusion of the infarct-related artery without an increase in major bleeding in patients with STEMI (ST-elevation myocardial infarction) undergoing percutaneous coronary intervention (PCI) (28 Oct)
COMMERCIAL
- Be Bio raised $82M to advance its gene therapy, B-101, to Phase 1/2 BeCoMe-9 trial in adults with moderately severe to severe haemophilia B. B-101 is a potentially first-in-class engineered B Cell Medicines (BCM), enabling continuous expression of active Factor IX (22 Oct)
