哮喘新药物Nucala(mepolizumab 中文药名：美泊利单抗)-2015年11月4日获美国FDA批准用于12岁年龄和以上患者与其他哮喘药物使用为维持哮喘治疗。
FDA的药品评价和研究中心中肺，过敏，和风湿病产品部主任Badrul Chowdhury，M.D.，Ph.D说：“这个批准提供有严重哮喘患者当当前治疗不能维持他们的哮喘适当控制时一个另外治疗，”。
批准日期：2015年11月4日；公司: GlaxoSmithKline plc
NUCALA（美泊利单抗），用于注射，用于皮下使用
美国首次批准：2015年
适应症和用法
NUCALA是白介素5拮抗剂单克隆抗体（IgG1的卡帕）表示为附加维持治疗重症哮喘患者年龄在12岁以上，并有嗜酸性粒细胞表型。
使用限制：
•不为治疗其他嗜酸性条件。
•不为救济急性支气管痉挛或哮喘持续状态。
用法用量
100毫克皮下给药一次，每4周。
•请参阅完整的处方信息对重建冻干粉及其制备方法和管理注入指令。
剂型和规格
注射：冻干粉末在单一剂量小瓶用于重100毫克。
禁忌
过敏史，以美泊利单抗或制剂辅料。
警告和注意事项
•过敏反应（如血管神经性水肿，支气管痉挛，低血压，荨麻疹，皮疹）NUCALA给药后发生。在过敏反应时中止NUCALA。
•不要用它来治疗急性支气管痉挛或哮喘持续状态。
•带状疱疹感染发生在收到NUCALA患者。考虑水痘疫苗接种，如果在开始治疗NUCALA之前，医学上是适当。
•突然在治疗与NUCALA开始不要停止全身或吸入糖皮质激素。减少糖皮质激素逐渐，如果合适的话。
•治疗病人的治疗NUCALA前预先存在的蠕虫感染。如果患者感染而接受与NUCALA处理，不抗蠕虫治疗反应，停止NUCALA直到寄生虫感染结算。
不良反应
最常见的不良反应（发生率大于或等于5％）包括头痛，注射部位反应，腰痛，和疲劳。
包装规格/储存与处理
NUCALA被作为一个无菌的，不含防腐剂的冻干粉末用于复原和皮下注射在纸箱1单剂量的玻璃小瓶和倒装断密封。将小瓶塞子不与天然橡胶胶乳制成。 NUCALA可作为：
100毫克单剂量小瓶（NDC0173-0881-01）。

存储低于25°C（77°F）。不要冷冻。存放在原包装避光。
Nucala, mepolizumab (SB-240563) (formerly Bosatria)
GlaxoSmithKline has received approval from the FDA for Nucala as an add-on maintenance treatment of patients with severe asthma aged 12 years and older, who have an eosinophilic phenotype.
Nucala (mepolizumab) is now approved for patients who have a history of severe asthma attacks (exacerbations), despite receiving their current asthma medicines.
“This approval offers patients with severe asthma an additional therapy when current treatments cannot maintain adequate control of their asthma,” says Badrul Chowdhury, director of the division of pulmonary, allergy, and rheumatology products in the FDA’s Center for Drug Evaluation and Research.
Nucala is the first and only approved biologic therapy that targets interleukin-5 (IL-5), which plays an important role in regulating the function of eosinophils, an inflammatory cell known to be important in asthma. Studies suggest that approximately 60% of patients with severe asthma have eosinophilic airway inflammation.
Patients will receive Nucala in addition to their normal medications for severe asthma, which include high-dose inhaled corticosteroids plus at least one additional asthma control medicine, and in some cases oral corticosteroids. 
Doctors generally try to avoid prescribing corticosteroids where possible, due to adverse side effects including osteoporosis and high blood pressure, and it is believed has the potential to reduce such prescriptions.              
This is the first marketing authorisation granted for Nucala anywhere in the world. It follows three Phase III trials which established that, compared with placebo, patients with severe asthma receiving Nucala had fewer exacerbations requiring hospitalisation and/or emergency department visits, and a longer time to their first exacerbation.
Patients with severe asthma receiving Nucala also experienced greater reductions in their daily maintenance oral corticosteroid dose, while maintaining asthma control compared with patients receiving placebo.
Treatment with mepolizumab did not however result in a significant improvement in lung function, as measured by the volume of air exhaled by patients in one second.
Eric Dube, senior vice president and head of GSK’s global respiratory franchise says: “Following today’s approval, GSK can now offer, as part of our overall respiratory portfolio, a first-in-class biologic treatment for severe asthma patients whose condition is driven by eosinophilic inflammation.
“Our research has allowed us to better understand the specific role eosinophils play in severe asthma. We are proud of our contribution to this emerging area of science that has led to the approval of the first anti-IL5 treatment. We aim to offer this medicine to patients as soon as possible.”
Patients who were shown to benefit from treatment with Nucala in the Phase III clinical trials were those with blood eosinophil levels of 150 cells/mcL or greater just prior to treatment.
Professor Ian Pavord of University of Oxford, lead investigator of the first proof of concept trial and a Phase III study of mepolizumab, comments: “Severe asthma is a debilitating condition in which patients are at high risk of frequent and serious asthma attacks. Half of all severe asthma patients have at least one urgent care visit per year. As a clinician, the prospect of a treatment that can specifically target the underlying cause of the disease for patients whose condition is driven by eosinophilic inflammation is exciting.”
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fefb887c-e4ac-431e-8893-e9d1a5a63fea