FDA批准了Eliquis的首个仿制药

毒手药王邓智先

FDA approves first generics of Eliquis

FDA批准了Eliquis的首个仿制药

December 23, 2019

2019年12月23日

The U.S. Food and Drug Administration has approved two applications for the first generics of Eliquis (apixaban) tablets to reduce the risk of stroke and systemic embolism ['ɛmbə,lɪzəm] 血管栓塞 in patients with nonvalvular atrial fibrillation非瓣膜性房颤. Apixaban is also indicated for the prophylaxis  [,profɪ'læksɪs] 预防of deep vein thrombosis [θrɑm'bosɪs] 血栓 (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. Additionally, apixaban is indicated for the treatment of DVT and PE and for the reduction in the risk of recurrent DVT and PE following initial therapy.

美国食品和药品管理局批准了两项Eliquis(阿哌沙班)片的首仿申请，阿哌沙班能降低非瓣膜性房颤患者中风和体循环动脉栓塞风险。阿哌沙班还用于预防深静脉血栓形成，在患者髋关节或膝关节置换手术中，深静脉血栓可导致肺栓塞。此外，阿哌沙班还用于治疗深静脉血栓和肺栓塞，降低初始治疗后深静脉血栓和肺栓塞的复发风险。

“Today’s approvals of the first generics of apixaban are an example of how the FDA’s generic drug program improves access to lower-cost, safe and high-quality medicines,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “These approvals mark the first generic approvals of a direct oral anticoagulant. Direct oral anticoagulants (blood thinners) do not require repeated blood testing.”

“今日阿哌沙班首仿的批准是FDA仿制药项目提高大众对低价、安全和高质量药品的获取机会的又一证明，”FDA药物评价与研究中心主任Janet Woodcock博士说到。“这两项批准标志着直接口服抗凝药的首仿批准。直接口服抗凝药（血液稀释剂）不需要进行重复血液检测。”

Addressing the challenges related to developing generics and promoting more generic competition is a key part of the FDA’s Drug Competition Action Plan and the agency’s efforts to help increase patient access to more affordable medicines.

提示仿制药开发风险、促进更多仿制药竞争是《药物竞争行动计划》的重要一环，也是机构帮助患者获得负担得起的药品的努力体现。

For at-risk patients, such as those with, or at risk for, DVT, or nonvalvular atrial fibrillation, the risk of stroke related to blood clots forming in the body and traveling to the brain is a serious concern. Atrial fibrillation is a heart rhythm problem that can potentially cause such blood clots. According to the Centers for Disease Control and Prevention, it is estimated that between 2.7 and 6.1 million people in the U.S. have atrial fibrillation. Many of these individuals use anticoagulants or anti-clotting drugs to reduce that risk.

对于深静脉血栓或非瓣膜性房颤的高危患者，体内血块形成并转移至脑内引发中风是一种非常严重的情况。房颤是一种心率障碍，可能会引起血块形成。根据疾病控制和预防中心估计，美国有270万到610万房颤患者。其中多数患者使用抗凝剂或抗凝血药物降低中风风险。

Apixaban will be dispensed with a Medication Guide for patients that provides instructions on its use and drug safety information. Health care professionals should counsel patients on signs and symptoms of possible bleeding.

阿哌沙班发放时，患者能拿到用药指南，用药指南对药物使用和药物安全性进行了介绍。医护专家应告知患者可能的出血指征和症状。

There is an increased risk of thrombotic events, which occur when blood clots form inside a blood vessel, or strokes if a patient stops using apixaban too early. Additionally, epidural or spinal hematomas (bleeding outside of blood vessels) may occur in patients treated with apixaban who are receiving neuraxial anesthesia 椎管内麻醉or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Health care professionals should consider these risks when scheduling patients for spinal procedures.

如果阿哌沙班停药过早，患者血管内可能会形成血块，会导致栓塞事件风险增大或引发中风。此外，接受椎管内麻醉术或脊髓穿刺术而使用阿哌沙班的患者可能会出血硬脊膜外血肿（血管外出血）。这类血肿可能引起长期或永久性麻痹。医护专家安排患者脊髓手术时，应考虑这些风险。

Patients with prosthetic [prɑs'θɛtɪk]假体的 heart valves should not take apixaban nor should patients with atrial fibrillation that is caused by a heart valve problem. As with other FDA-approved anti-clotting drugs, bleeding, including life-threatening and fatal bleeding, is the most serious risk with apixaban.

装有人工心脏瓣膜的患者或由心脏瓣膜问题引发的房颤患者都不应服用阿哌沙班。因为和其他FDA批准的抗凝血药一样，包括危机生命和致命性出血在内的出血是阿哌沙班最重大的风险。

The FDA granted approval of the generic apixaban applications to Micro Labs Limited and Mylan Pharmaceuticals Inc. Please contact the manufacturers for information about the medicine’s availability.

FDA将阿哌沙班仿制药申请的批准授予了Micro 实验有限公司和迈兰制药股份有限公司。请联系厂家咨询药品的获取渠道。

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