AstraZeneca's Asthma Drug Gets FDA Approval For Rare Disease Of Blood Vessel Inflammation
AstraZeneca's Asthma Drug Gets FDA Approval For Rare Disease Of Blood Vessel Inflammation
MANDARA was the first head-to-head non-inferiority trial of biologics in patients with EGPA.The FDA approved on Wednesday AstraZeneca Plc's (NASDAQ:AZN) Fasenra (benralizumab) for eosinophilic granulomatosis with polyangiitis (EGPA), a rare, immune-mediated vasculitis (inflammation of the blood vessels) that can result in damage to multiple organs.
美国食品和药物管理局周三批准了阿斯利康股份有限公司（纳斯达克:AZN）的法塞尼拉（苯拉鲁单抗）用于嗜酸性肉芽肿性肉芽肿性多脏器炎（EGPA），这是一种罕见的免疫介导的血管炎（血管炎症），可能导致多个器官受损。
The approval was based on data from the MANDARA Phase 3 trial published in The New England Journal of Medicine, which compared the efficacy and safety of Fasenra to the only approved EGPA treatment, GSK Plc's (NYSE:GSK) Nucala (mepolizumab).
批准是基于《新英格兰医学杂志》发表的MANDARA第3期试验数据，该数据比较了法塞尼拉与唯一获批的EGPA治疗方法，GSK股份有限公司（纽交所:GSK）的努卡拉（米珀利酞）的疗效和安全性。
Also Read: AstraZeneca CEO Pascal Soriot Updates On Chinese Compliance Probe And Lung Cancer Drug Trial Results
阿斯利康CEO帕斯卡尔·索里奥特更新了中国合规调查和肺癌药物试验结果。
MANDARA was the first head-to-head non-inferiority trial of biologics in patients with EGPA.
MANDARA是关于EGPA患者的首个头对头的非劣效试验。
In the trial, nearly 60% of Fasenra-treated patients achieved remission, comparable to mepolizumab-treated patients.
在试验中，近60%的法塞尼拉治疗患者实现了缓解，与米珀利酞治疗患者相当。
Data also showed 41% of Fasenra-treated patients fully tapered off oral corticosteroids (OCS) (vs. 26% in the mepolizumab arm).
数据还显示，41%的法塞尼拉治疗患者完全停用口服皮质类固醇（OCS）（相对于米珀利酞组的26%）。
The safety and tolerability profile for Fasenra in the MANDARA trial was consistent with the known profile of the medicine.
在MANDARA试验中，法塞尼拉的安全性和耐受性与药物已知的特性一致。
Approximately half of patients with EGPA have adult-onset severe eosinophilic asthma and often have sinus and nasal symptoms. Fasenra is the second biologic approved to treat this disease.
大约一半的EGPA患者患有成人发病的重度嗜酸性哮喘，通常伴有鼻窦和鼻部症状。法塞尼拉是第二个获批用于治疗该疾病的生物制品。
Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in over 80 countries.
Fasenra目前已在80多个国家批准用作重度嗜酸粒细胞性哮喘的辅助维持治疗。
It is also approved in children and adolescents ages six and above in the U.S. and Japan.
它还在美国和日本批准用于6岁及以上的儿童和青少年。
Last month, the FDA approved AstraZeneca's Imfinzi (durvalumab) in combination with chemotherapy for adult patients with resectable early-stage non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements.
上个月，FDA批准了AstraZeneca的Imfinzi（durvalumab）与化疗联合治疗可切除期早期非小细胞肺癌（NSCLC）成人患者，并且没有已知的表皮生长因子受体突变或间变性淋巴瘤激酶重排。
AZN Price Action: AstraZeneca stock is down 0.16% at $78.41 at publication Wednesday.
AZN股票价格：AstraZeneca股票在周三发布时下跌0.16％，为78.41美元。
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Photo: Shutterstock
Photo: shutterstock
