Nucala(mepolizumab)用于12岁及以上严重哮喘

 By：HAOEYOU（好医友） 

The U.S. Food and Drug Administration today approved Nucala (mepolizumab) for use with other asthma medicines for the maintenance treatment of asthma in patients age 12 years and older. Nucala is approved for patients who have a history of severe asthma attacks (exacerbations) despite receiving their current asthma medicines.

2015年11月4日，美国食品和药物管理局（ FDA） 批准 Nucala（mepolizumab ）美泊利单抗用于 12 岁及以上年龄的患者，并与其它哮喘药物一起用于哮喘的维持性治疗。Nucala 被批准用于那些目前仍在使用哮喘治疗药物，但依然有严重哮喘发作史的患者。

Asthma is a chronic disease that causes inflammation in the airways of the lungs. During an asthma attack, airways become narrow making it hard to breathe. Severe asthma attacks can lead to asthma-related hospitalizations because these attacks can be serious and even life-threatening. According to the Centers for Disease Control and Prevention, as of 2013, more than 22 million people in the U.S. have asthma, and there are more than 400,000 asthma-related hospitalizations each year.

哮喘是一种慢性疾病，能够引起肺部呼吸道炎症。在哮喘发作期间，呼吸道变窄，使得患者难以呼吸。严重哮喘发作可导致相关性哮喘症状而住院，因为这些发作可能是严重的，甚至是危及生命的。据美国疾病控制与预防中心的统计，截至2013年，在美国有超过2200 万人得过哮喘，每年有超过40万哮喘相关住院病例。

 

“This approval offers patients with severe asthma an additional therapy when current treatments cannot maintain adequate control of their asthma,” said Badrul Chowdhury, M.D., Ph.D., director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.

FDA药品评价与研究中心，肺部、过敏及风湿病产品部门主任、医学、哲学双博士巴德鲁·乔杜里（Badrul Chowdhury） 称，此次的批准为严重哮喘患者提供了一种额外的治疗选择，可以在目前治疗药物无法达到充分控制哮喘时，进行维持性治疗。

 

Nucala is administered once every four weeks by subcutaneous injection by a health care professional into the upper arm, thigh, or abdomen. Nucala is a humanized interleukin-5 antagonist monoclonal antibody produced by recombinant DNA technology in Chinese hamster ovary cells. Nucala reduces severe asthma attacks by reducing the levels of blood eosinophils- a type of white blood cell that contributes to the development of asthma.

Nucala每四周注射一次，由卫生保健专业人员经上臂、大腿或腹部皮下注射使用。Nucala是一种人性化白介素-5拮抗剂单克隆抗体，在中国仓鼠卵巢细胞中通过 DNA 重组技术产生。Nucala通过降低血嗜酸性粒细胞水平而降低严重哮喘发作，血嗜酸性粒细胞是白细胞的一种，它对哮喘的发生起到促进作用。

 

The safety and efficacy of Nucala were established in three double-blind, randomized, placebo?controlled trials in patients with severe asthma on currently available therapies. Nucala or a placebo was administered to patients every four weeks as an add-on asthma treatment. 

Nucala的安全性与有效性基于在使用目前可用治疗药的严重哮喘患者中进行的三项双盲、随机、安慰剂对照试验。Nucala或安慰剂每四周作为一种辅助哮喘治疗药物用于患者。与安慰剂相比，接受Nucala治疗的严重哮喘患者住院率和发作率大幅度降低，并且首次发作的间隔时间更长。

 

Compared with placebo, patients with severe asthma receiving Nucala had fewer exacerbations requiring hospitalization and/or emergency department visits, and a longer time to the first exacerbation. In addition, patients with severe asthma receiving Nucala experienced greater reductions in their daily maintenance oral corticosteroid dose, while maintaining asthma control compared with patients receiving placebo. Treatment with mepolizumab did not result in a significant improvement in lung function, as measured by the volume of air exhaled by patients in one second.

此外，接受Nucala治疗的严重哮喘患者中，每天用于维持治疗的口服糖皮质激素的剂量有了更大程度的降低，同时与接受安慰剂的患者相比也能维持哮喘控制。以患者一秒钟呼出气体体积作为指标，美泊利单抗治疗未导致肺功能明显的改善。

 

The most common side effects of Nucala include headache, injection site reactions (pain, redness, swelling, itching, or a burning feeling at the injection site), back pain, and weakness (fatigue). Hypersensitivity reactions can occur within hours or days of being treated with Nucala, including swelling of the face, mouth, and tongue; fainting, dizziness, or lightheadedness; hives; breathing problems and rash. Herpes zoster infections have occurred in patients receiving Nucala. Herpes zoster is the virus that causes shingles.

Nucala最常见的副作用包括头痛、注射部位反应（疼痛、发红、肿胀、瘙痒或注射部位有灼热感觉）、背部疼痛和虚弱（疲劳）。在 Nucala 治疗的数小时或数天内可发生超敏反应，包括脸肿、嘴和舌头肿胀、昏厥、头晕、麻疹、呼吸困难和皮疹。在接受 Nucala 治疗患者中发生过带状疱疹感染。带状疱疹感染是一种能引起带状疱疹的病毒。