2017年12月21日，美国食品和药品监管局今天批准Giapreza (血管紧张素angiotensin II) 注射为成年中有败血症或其他分配性休克静脉输注增加血压。
FDA的药品评价和研究中心中心血管和肾产品部主任Norman Stockbridge，M.D.，Ph.D.说："休克，不能维持血流至生命组织，可能导致器官衰竭和死亡，" "对危重地生病不能对可得到的治疗适当反应的低血压患者这是一个需求的治疗选择。"
血压是当心脏泵出血液时推向动脉的血管壁的一种力量。低血压是异常地低血压。休克是一种危重情况其中血压掉至如此低，使大脑，肾脏和其他生命器官不能接受足够血流至适当地功能。
在一项321例有休克和一个危重低血压患者临床试验，与用安慰剂治疗患者比较显著地更多患者对用Giapreza治疗反应。Giapreza有效地增加血压当加入至用于升高血压的常用治疗。
Giapreza可能致危险的血凝块有严重的后果(凝块在动脉和静脉，包括深部静脉血栓形成)；应被使用对血液凝固预防性治疗。
这个申请接受一个优先审评，在它下FDA的目的是采取行动用一个申请在6个月内当监管局决定该药物，如被批准，将显著地改善治疗，诊断或预防一种严重情况安全或有效。
FDA授予La Jolla制药公司Giapreza的批准
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm590249.htm
Giapreza(synthetic human angiotensin II)
GIAPREZA(angiotensin II) increases blood pressure in adults with septic or other distributive shock.
Contraindications
None.
Warnings and Precautions
The safety of GIAPREZA was eva luated in 321 adults with septic or other distributive shock in the randomized, double-blind, placebo-controlled ATHOS-3 study. There was a higher incidence of arterial and venous thrombotic and thromboembolic events in patients who received GIAPREZA compared to placebo treated patients in the ATHOS-3 study [13% (21/163 patients) vs. 5% (8/158 patients)]. The major imbalance was in deep venous thromboses. Use concurrent venous thromboembolism prophylaxis.
Adverse Reactions
The most common adverse reactions reported in greater than 10% in GIAPREZA-treated patients were thromboembolic events. Adverse reactions occurring in ≥4% of patients treated with GIAPREZA and ≥1.5% more often than placebo-treated patients in the ATHOS-3 study were thromboembolic events (including deep vein thrombosis), thrombocytopenia, tachycardia, fungal infection, delirium, acidosis, hyperglycemia, and peripheral ischemia.
Drug Interactions
Angiotensin converting enzyme inhibitors may increase response to GIAPREZA.
Angiotensin II receptor blockers may reduce response to GIAPREZA. |
