重度哮喘新药Fasenra(benralizumab)获FDA)批准上市，可降低近51%
2017年11月16日，美国食品和药物管理局(FDA)批准了Fasenra(benralizumab)重度哮喘药，作为一种附加的维持疗法，主要用于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。年哮喘发作率与安慰剂组相比降低近51%。
fasenra是唯一一种在给药后24h内能提供直接、快速、嗜酸性粒细胞几乎完全耗尽的呼吸科生物疗法。据估计，在重度哮喘患者中，大约有一半的患者嗜酸性粒细胞水平升高，影响气道炎症和气道高反应性，导致哮喘严重程度和症状加重，肺功能下降，急性加重风险升高。
fasenra直接结合在一个嗜酸性粒细胞IL-5α受体和独特的吸引自然杀伤细胞诱导细胞凋亡(程序性细胞死亡)。Fasenra将作为一个每周固定剂量皮下注射经预灌封注射器。
结果显示，接受8周benralizumab给药方案的患者：
(1)年哮喘发作率与安慰剂组相比降低近51%
(2)第一次注射后4周内，效果明显。显著改善肺功能，测定第1秒用力呼气容积(FEV1)比安慰剂高159ml。
(3)每日使用OCS的人数平均减少75%，且有52%符合条件的患者停用OCS
(4)在安全性方面，使用不良事件与安慰剂相同。

Fasenra(Benralizumab for Subcutaneous Injection)
FASENRA Rx
Generic Name and Formulations:
Benralizumab 30mg/mL; soln for SC inj; preservative-free.
Company:
AstraZeneca Pharmaceuticals
Indications for FASENRA:
As add-on maintenance treatment of severe asthma in patients ≥12yrs old, and with an eosinophilic phenotype.
Limitations Of use:
Not for treating other eosinophilic conditions. Not for relief of acute bronchospasm or status asthmaticus.
Adult:
Give by SC inj into upper arm, thigh, or abdomen. 30mg once every 4 weeks for the first 3 doses, then once every 8 weeks thereafter.
Children:
Not established.
Warnings/Precautions:
Not for treating acute asthma symptoms or exacerbations. Discontinue if hypersensitivity reactions occur. Treat pre-existing helminth infections before initiating therapy; discontinue Fasenra if treatment-resistant infection occurs while on therapy until resolves. Avoid abrupt discontinuation of systemic or inhaled corticosteroids; reduce dose gradually upon Fasenra initiation, if appropriate. Reduction may be associated with systemic withdrawal symptoms and/or unmask previously suppressed conditions. Pregnancy. Nursing mothers.
Pharmacological Class:
Interleukin-5 antagonist.
Adverse Reactions:
Headache, pharyngitis, pyrexia, hypersensitivity reactions.
Generic Availability:
NO
How Supplied:
Single-dose prefilled syringe—1