2021年03月18日,Kiniksa Pharmaceuticals宣布,美国FDA已批准该公司开发的IL-1抑制剂Arcalyst(rilonacept)上市,用于治疗12岁以上复发性心包炎(recurrent pericarditis)患者和减轻心包炎的复发风险。 什么是复发性心包炎 复发性心包炎是一种影响心脏周围组织的炎症性疾病,它影响15%至30%的急性心包炎患者。复发性心包炎...
Break free from future flares with ARCALYST® (rilonacept), the first and only FDA approved therapy for Recurrent Pericarditis.
2021年03月18日,Kiniksa Pharmaceuticals宣布,美国FDA已批准该公司开发的IL-1抑制剂Arcalyst(rilonacept)上市,用于治疗12岁以上复发性心包炎(recurrent pericarditis)患者和减轻心包炎的复发风险。 Arcalyst(rilonacept)是首款获得FDA批准的复发性心包炎疗法。 FDA的批准是基于名为RHAPSODY的关键性3期临床试验结果。 试验...
Arcalyst is not a cure for these inherited conditions. Arcalyst is also used to reduce episodes of recurrentpericarditis(RP) in adults and children at least 12 years old. RP can cause pounding heartbeats, trouble breathing, and severe chest pain spreading to your back or neck. ...
for recurrent pericarditis, cryopyrin-associated periodic syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome and Xxxxxx-Xxxxx Syndrome, and deficiency of IL-1 receptor antagonist (DIRA).The FDAgrantedBreakthrough Therapy designationto ARCALYST for thetreatment ofrecurrent pericarditis in 2019...
在这一组中,约有14000名患者由于持续的内在疾病或对传统疗法(如非甾体抗炎药、秋水仙碱和皮质类固醇)反应不足而经历第二次或随后的事件(复发)。(生物谷Bioon.com) 原文出处:Kiniksa AnnouncesFDAapproval of ARCALYST ® (rilonacept) for Recurrent Pericarditis...