pp-250 Injection
Dossier type
EU CTD
Dossier status
Under development
Country of origin
Switzerland
GMP approvals
EU GMP
Comments
Indication: Atrial fibrillation (moderate-to-high stroke risk, unsuitable for anticoagulation); venous thromboembolism (VTE) cancer-associated / Clinical stage: Phase 3 / Modality: Monoclonal antibody / Mechanism & Target: Factor XI (FXI) and Factor XIa (FXIa) inhibition via zymogen conformation lock / Route & form: Subcutaneous injection / Differentiation: First FXI inhibitor in Phase 3 VTE; reduced bleeding vs direct anticoagulants (3.2 events/100py vs 8.4 rivaroxaban in AFib Phase 2)
Manufacturer #6157
| Specialty biopharmaceutical company focused on rare hematological, immunological, and inflammatory diseases. Develops targeted biologics and small molecules for high unmet medical need conditions. Advances Phase 3 programs through a global development and commercialization network. |
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