新型哮喘抗炎药Fasenra(benralizumab) 获美国、欧洲及日本批准上市，作为一种附加（add-on）维持疗法，用于12岁及以上重度嗜酸性粒细胞性哮喘青少年患者及成人患者的治疗。Fasenra每8周一次皮下注射，将作为一种含固定剂量药物的预充式注射器。

ファセンラ皮下注30mgシリンジ

药物分类名称
人源化抗IL-5受体α单克隆抗体制剂
批准日期：2018年4月
欧文商標名
FASENRA(R) Subcutaneous Injection 30mg Syringe
一般名：ベンラリズマブ（遺伝子組換え）
Benralizumab(Genetical Recombination)
本　質：
Benzalizumab是一种重组人源化单克隆抗体，由确定小鼠抗人白细胞介素-5受体α亚基抗体部分的互补性，框架部分和人IgG1的恒定部分组成。Benlizumab由中国仓鼠卵巢细胞产生，其缺乏糖蛋白6-α-L岩藻糖基转移酶。 Benelizumab是一种糖蛋白（分子量：约148,000），由2个H链（γ1链）组成，由451个氨基酸残基组成，2个链（κ链）由214个氨基酸残基组成。
处理注意事项
1.请勿剧烈摇晃本产品。
2.避免冷冻本产品，如果冷冻则不要使用。
3.为避免光线照射，本产品应存放在外箱中。
批准条件
制定药品风险管理计划并适当实施。
药用药理学
作用机制
该试剂是岩藻糖缺陷的人源化免疫球蛋白G亚类1，kappa型同种型（IgG1κ）针对人白细胞介素-5受体α亚基（IL-5Rα）的单克隆抗体。 该试剂以高亲和力（解离常数：16pM）与人IL-5Rα和Fc结构域的岩藻糖缺乏结合，在效应细胞如天然杀伤细胞上产生高亲和力（FcγRIIIa） 常数：45.5nM）诱导表达IL-5Rα的嗜酸性粒细胞和嗜碱性粒细胞的凋亡。
适应症
支气管哮喘（仅限于即使通过现有治疗也无法控制哮喘症状的患者）
用法与用量
成人；第一次，4周，8周后皮下注射30 mg一次Venlizumab（遗传重组），随后以8周为间隔皮下注射
包装
皮下注射：30mg注射器：1个试剂盒
制造供应商
阿斯利康公司

完整说明书附件：http://www.info.pmda.go.jp/go/pack/2290402G1020_1_01/
Remove eosinophils that severely asthma directly and promptly
AstraZeneca Co.Ltd.(Headquarters: Osaka-shi Kita-ku, President: Stefan-Voxstrum, hereinafter referred to as AstraZeneca) announced that "bronchial asthma(limited to patients who are incapable of controlling asthma symptoms even by existing treatments)·We announced that we released "Fascena® subcutaneous injection 30 mg syringe" (generic name: Benelizumab(genetical recombination), hereinafter referred to as "Fassela")as an effect.
Fasciella is a humanized anti-IL-5 receptor α monoclonal antibody (NK cell) that directly and rapidly removes eosinophils in the blood and respiratory tract by ADCC(antibody dependent cellular cytotoxicity)activity It is a preparation.
Phase I studies have confirmed that eosinophils are quickly removed within 24 hours. It has also been confirmed to remove eosinophils in sputum in the airway tissue.
Fasela is an injection of a prefilled syringe with a needle stick prevention function and is injected subcutaneously at the first time, 4weeks, and 8weeks, then injected subcutaneously at 8week intervals. Fassela has been approved in the United States, Europe, Japan, Australia and Canada, and it is applying for approval in several other countries.
Approximately 8 million people in Japan are estimated to suffer from asthma, of which 5 to 10% of patients have high-dose inhaled corticosteroids(ICS), as well as other long-term It is said to be a serious asthma that requires treatment with administration medications and/or systemic corticosteroids, or poor control despite these treatments.
In addition, eosinophil level tends to be high in about 50% of patients with severe asthma, elevation of eosinophil level causes airway inflammation and airway hyperresponsiveness, resulting in decreased asthma exacerbation and respiratory function, Asthma exacerbation risk rises, asthma becomes severe.
About Fascena® subcutaneous injection 30mg syringe (common name: Benelizumab (genetical recombination))
Fasciella is a monoclonal antibody that natural killer cells(NK cells) directly and quickly remove eosinophils in the blood and airways due to ADCC (antibody dependent cellular cytotoxicity) activity.
Phase I study has confirmed that blood eosinophils are quickly removed within 24 hours.It has also been confirmed to remove eosinophils in sputum in the airway tissue.Eosinophils become biological effector cells in about 50% of patients with asthma, causing frequent asthma exacerbation, decreased respiratory function, and worse asthma symptoms. Fasela is an injection of a prefilled syringe with a needle stick prevention function, which is injected subcutaneously at the first time, 4weeks, and 8weeks after injection once, subcutaneously at intervals of 8 weeks.
Fassela is currently approved in the US, EU, Japan, Australia and Canada and is currently pending approval in several other countries.
Faselera is currently developing as a therapeutic agent for chronic obstructive pulmonary disease (COPD) as the basis of a biological product portfolio that can be a new drug to investigate the root cause of respiratory diseases in the respiratory disease area of AstraZeneca Results will be obtained in the second half of 2018.
Fasenra was introduced by BioWa, a wholly-owned subsidiary of Kyowa Hakko Kirin, and was developed by AstraZeneca's global biopharmaceutical research and development department, Medimune and Kyowa Hakko Kirin. AstraZeneca possesses sales rights for asthma and COPD in Japan and other Asian countries and all development and marketing rights in world markets other than Japan and other Asian countries.
About severe asthma
Approximately 8million people in Japan are estimated to suffer from asthma. According to the guideline on severe asthma of the European Respiratory Society (ERS)and the American Society of Thoracic Diseases(ATS), in addition to high-dose inhaled corticosteroids, severe asthma is treated with other long-term management drugs(and/or systemic steroid drugs)It is defined as asthma that requires treatment by treatment, or "a poor control" regardless of such treatment, and it is said to be 5 to 10% of all asthma patients.
Severe asthma with poor control is a severe disease that can lead to death. Patients have a physical burden of frequent symptom exacerbation and decreased respiratory function, a remarkable decline in quality of life(QOL), etc. Social economy It is forced to bear a burden.
For the treatment of severe asthma, phenotype (phenotype) of eosinophilic, neutrophilic, allergic, chronic airflow obstruction, repetition of exacerbation, insensitivity to corticosteroids is considered from the background and clinical features of the patient, Has been applied for treatment selection.
Treatment of severe asthma may cause oral steroid dependence and administration of systemic steroid may cause severe side effects including weight gain, diabetes, osteoporosis, glaucoma, anxiety, depression, cardiovascular disease and immunosuppression as short term It may occur for a long time or between.