NOVEL STABLE HIGH-CONCENTRATION FORMULATION FOR ANTI-FXIa ANTIBODIES

The present invention refers to novel liquid pharmaceutical high-concentration formulations particularly suitable for subcutaneous administration comprising human antibodies against coagulation factorFXIa as active ingredient, especially those described in WO2013167669, which are stable as liquid formulations over a long period. The invention also refers to lyophilizates of the specified liquid formulation with reduced reconstitution time and also to the use of these formulations in the therapy and prophylaxis of thrombotic or thromboembolic disorde. 本发明涉及特别适合于皮下给药的新型液体药物高浓度制剂，其包含针对凝血因子FXIa的人抗体作为活性成分，尤其是在WO2013167669中记载的那些，该制剂作为液体制剂长期稳定。本发明还涉及重构时间减少减少的特定液体制剂的冻干物，并且还涉及这些制剂在治疗和预防血栓形成性疾病或血栓栓塞性疾病中的用途。