By：HAOEYOU（好醫(yī)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，美國食品和藥物管理局（ FDA） 批準(zhǔn) Nucala（mepolizumab ）美泊利單抗用于 12 歲及以上年齡的患者，并與其它哮喘藥物一起用于哮喘的維持性治療。Nucala 被批準(zhǔn)用于那些目前仍在使用哮喘治療藥物，但依然有嚴(yán)重哮喘發(fā)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.

哮喘是一種慢性疾病，能夠引起肺部呼吸道炎癥。在哮喘發(fā)作期間，呼吸道變窄，使得患者難以呼吸。嚴(yán)重哮喘發(fā)作可導(dǎo)致相關(guān)性哮喘癥狀而住院，因為這些發(fā)作可能是嚴(yán)重的，甚至是危及生命的。據(jù)美國疾病控制與預(yù)防中心的統(tǒng)計，截至2013年，在美國有超過2200 萬人得過哮喘，每年有超過40萬哮喘相關(guān)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藥品評價與研究中心，肺部、過敏及風(fēng)濕病產(chǎn)品部門主任、醫(yī)學(xué)、哲學(xué)雙博士巴德魯·喬杜里（Badrul Chowdhury） 稱，此次的批準(zhǔn)為嚴(yán)重哮喘患者提供了一種額外的治療選擇，可以在目前治療藥物無法達(dá)到充分控制哮喘時，進(jìn)行維持性治療。

 

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，由衛(wèi)生保健專業(yè)人員經(jīng)上臂、大腿或腹部皮下注射使用。Nucala是一種人性化白介素-5拮抗劑單克隆抗體，在中國倉鼠卵巢細(xì)胞中通過 DNA 重組技術(shù)產(chǎn)生。Nucala通過降低血嗜酸性粒細(xì)胞水平而降低嚴(yán)重哮喘發(fā)作，血嗜酸性粒細(xì)胞是白細(xì)胞的一種，它對哮喘的發(fā)生起到促進(jìn)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的安全性與有效性基于在使用目前可用治療藥的嚴(yán)重哮喘患者中進(jìn)行的三項雙盲、隨機(jī)、安慰劑對照試驗。Nucala或安慰劑每四周作為一種輔助哮喘治療藥物用于患者。與安慰劑相比，接受Nucala治療的嚴(yán)重哮喘患者住院率和發(fā)作率大幅度降低，并且首次發(fā)作的間隔時間更長。

 

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治療的嚴(yán)重哮喘患者中，每天用于維持治療的口服糖皮質(zhì)激素的劑量有了更大程度的降低，同時與接受安慰劑的患者相比也能維持哮喘控制。以患者一秒鐘呼出氣體體積作為指標(biāo)，美泊利單抗治療未導(dǎo)致肺功能明顯的改善。

 

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最常見的副作用包括頭痛、注射部位反應(yīng)（疼痛、發(fā)紅、腫脹、瘙癢或注射部位有灼熱感覺）、背部疼痛和虛弱（疲勞）。在 Nucala 治療的數(shù)小時或數(shù)天內(nèi)可發(fā)生超敏反應(yīng)，包括臉腫、嘴和舌頭腫脹、昏厥、頭暈、麻疹、呼吸困難和皮疹。在接受 Nucala 治療患者中發(fā)生過帶狀皰疹感染。帶狀皰疹感染是一種能引起帶狀皰疹的病毒。