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FDA受理勃林格抗凝血剂Pradaxa第4个适应症

新药编辑:新特药 更新时间:2015-04-12

 

2015年4月7日讯 /tumor.net.cn/ --勃林格殷格翰(BI)近日宣布,FDA已受理抗凝血剂Pradaxa(dabigatran,达比加群酯)的补充新药申请(sNDA)。此次,勃林格寻求批准Pradaxa用于已接受原发性髋关节置换手术的患者,预防性治疗(prophylaxis)深静脉血栓(DVT)和肺栓塞(PE)。如果获批,这将成为Pradaxa的第4个适应症。

据估计,在美国每年开展近30万例全髋关节置换术。若不进行预防性治疗(例如,抗凝治疗预防血栓),深静脉血栓(DVT)在接受择期原发髋关节手术患者群体中的发生率高达40%-60%,而致死性肺栓塞(PE)的发生率约为五百分之一。

全髋关节置换术是一种常规手术,预防性抗凝治疗能显著改善患者的临床结果。Pradaxa sNDA的提交,是基于2项随机、双盲III期研究(RE-NOVATETM,RE-NOVATETM II)的积极数据。这些研究在接受全髋关节置换术患者中开展,调查了Pradaxa相对于依诺肝素(enoxaparin)在预防静脉血栓栓塞(VTE)和死亡事件的疗效和安全性。

Pradaxa最初于2010年获FDA批准上市,用于降低非瓣膜性房颤(NVAF)患者卒中和全身性栓塞风险。在2014年,FDA批准了Pradaxa 2个新的适应症,用于已接受5-10天肠外抗凝剂(parenteral anticoagulant)的患者,治疗深静脉血栓(DVT)和肺栓塞(PE),以及用于既往已治疗过的患者,降低DVT和PE复发的风险。

Pradaxa是德国制药巨头勃林格殷格翰(BI)开发的一款新型抗凝血药物,该药是继华法林之后50年来首个上市的抗凝血口服新药,是抗凝血治疗领域和潜在致死性血栓预防领域的又一个重要里程碑。Pradaxa具有口服、强效、无需特殊用药监测、药物相互作用少等优点,该药在市场上的主要竞争对手是拜耳和强生的拜瑞妥(Xarelto)和辉瑞的Eliquis。(tumor.net.cn)

英文原文:FDA Files Supplemental New Drug Application for Boehringer Ingelheim’s Pradaxa? (dabigatran etexilate mesylate) for the Prophylaxis of Deep Venous Thrombosis and Pulmonary Embolism After Hip Replacement Surgery

Ridgefield, CT, April 6, 2015 – Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) filed a supplemental New Drug Application (sNDA) for Pradaxa? (dabigatran etexilate mesylate) for the prophylaxis of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have had primary elective total hip replacement surgery. If approved, this will become the fourth indication for PRADAXA.

It is estimated that nearly 300,000 total hip replacement surgeries are performed each year in the United States. Without prophylaxis (e.g., anticoagulation treatment to prevent blood clots), the incidence of DVT detected by venography (x-ray visualization of the veins after administering injectable contrast dye) ranges from 40 percent to 60 percent of primary elective hip surgery patients, and fatal PE occurs in approximately one of 500 patients.

“Total hip replacement is a common procedure, and preventive anticoagulant treatment is recommended because of the potential for DVT and PE, which can be life-threatening for some patients,” said Sabine Luik, MD, senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “The acceptance of this sNDA is another step toward expanding the therapeutic uses for PRADAXA to improve patient outcomes in this population.”

The submission to the FDA is based on the results of two randomized, double-blind, phase III trials, RE-NOVATETM and RE-NOVATETM II. The studies compared the efficacy and safety of PRADAXA to enoxaparin in preventing venous thromboembolism (VTE) and death in patients undergoing total hip replacement surgery.

In RE-NOVATE, 3,494 patients having primary elective total hip replacement were randomized to three groups receiving prophylactic treatment with one of two doses of PRADAXA (220 mg or 150 mg) once daily or enoxaparin 40 mg once daily for 28 to 35 days. The first PRADAXA group was given a dose of 110 mg on the day of surgery and 220 mg daily thereafter; the second PRADAXA group received a dose of 75 mg on the day of surgery and 150 mg daily thereafter. The enoxaparin group was given a dose of 40 mg the day before surgery and daily thereafter.

The results showed patients taking PRADAXA 220 mg had a lower composite total of VTE (VTE comprises DVT and PE) and all-cause death (6.0 percent) than those on PRADAXA 150 mg (8.6 percent) and on enoxaparin 40 mg (6.7 percent). There was no significant difference in the rates of major bleeding among all treatment groups: 2.0 percent for PRADAXA 220 mg, 1.3 percent for PRADAXA 150 mg and 1.6 percent for enoxaparin 40 mg. The most common adverse events were gastrointestinal disorders, with similar frequencies in all treatment groups (PRADAXA 220 mg, 44.2 percent; PRADAXA 150 mg, 44.0 percent; enoxaparin 40 mg, 44.8 percent). Treatment with PRADAXA resulted in higher rates of wound secretion than enoxaparin (8.9 percent with PRADAXA 220 mg and 8.3 percent with PRADAXA 150 mg vs. 5.5 percent with enoxaparin).

In RE-NOVATE II, 2,055 patients undergoing primary elective total hip replacement were randomly assigned prophylactic treatment for 28 to 35 days with PRADAXA 220 mg once daily or enoxaparin 40 mg once daily. Patients receiving PRADAXA were treated with a dose of 110 mg on the day of surgery and 220 mg daily thereafter. The enoxaparin group was given a dose of 40 mg the day before surgery and daily thereafter. The results showed the composite total of VTE and all-cause death occurred in 7.7 percent of patients in the PRADAXA group vs. 8.8 percent of patients in the enoxaparin group. There was no difference in major bleeding rates between the two treatments (1.4 percent for patients on PRADAXA and 0.9 percent for patients on enoxaparin). Gastrointestinal disorders were the most frequent adverse events in the study, and were similar in both treatment groups (35.8 percent of PRADAXA patients vs. 35.7 percent of enoxaparin patients). The incidence of wound secretion was slightly higher for patients on PRADAXA (2.7 percent) than on enoxaparin (1.2 percent).

PRADAXA was initially approved by FDA in 2010 to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF). In 2014 FDA approved two additional indications for PRADAXA for the treatment of DVT and PE in patients who have been treated with a parenteral anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated.

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