Teva哮喘新产品ProAirRespiClick获FDA批准

2015年4月3日讯/生物谷BIOON/--以色列医药巨头Teva公司近日宣布其呼吸系统疾病新产品ProAirRespiClick获得了FDA批准，该产品是一种由呼吸驱动的干粉吸入器，内置了短效β受体激动剂（SABA）硫酸沙丁胺醇粉剂，用于12岁及以上哮喘患者，治疗和预防伴有可逆性阻塞性气道疾病的支气管痉挛，以及用于预防运动诱发性支气管痉挛。
“ProAirRespiClick是FDA批准用于治疗急性哮喘症状的首个也是唯一一个由呼吸驱动的干粉急救吸入器。对于急性哮喘发作的患者来言，简直是救命稻草！”美国辛辛那提大学医学院的免疫学、过敏和风湿疾病专家DavidI.Bernstein如此评价Teva的新药。“ProAirRespiClick另一个优势是服药简单，只需轻轻一吸，而不像其他产品需要双手和呼吸协调起来。”
梯瓦预计，ProAirRespiClick最快三个月内能够与广大患者见面。
Teva组织了八组临床试验，受试者都是患有哮喘或运动中发生呼吸痉挛的年过12岁的的青少年或成人，结果证明其是安全有效的。不良事件与沙丁胺醇吸入剂类似。
最常见的不良反应发生在>1%的受试者中，主要是背部疼痛，身体疼痛，肚子疼，窦性头疼以及尿道感染。
英文原文：FDAClearsFirstBreath-ActuatedDry-PowderSABAInhalerTheUSFoodandDrugAdministration(FDA)hasapprovedtheshort-actingbeta-agonist(SABA)albuterolsulfateinhalationpowder(ProAirRespiClick,Teva)forthetreatmentorpreventionofbronchospasmwithreversibleobstructiveairwaydiseaseandforpreventionofexercise-inducedbronchospasminpatientsaged12yearsorolder,thecompanyannouncedtoday.
"ProAirRespiClickisthefirstandonlybreath-actuated,dry-powderrescueinhalertobeapprovedbytheFDAforthetreatmentofacuteasthmasymptoms,"DavidI.Bernstein,MD,fromthedivisionofimmunology,allergyandrheumatology,UniversityofCincinnatiCollegeofMedicineinOhio,saidinacompanynewsrelease.
"TheapprovalofProAirRespiClickissignificantasiteliminatestheneedforhand-breathcoordinationduringinhalation,"headded.
Thecompanyexpectstheproducttobecomeavailableduringthenext3months.
ThesafetyandefficacyofProAirRespiClickwasdemonstratedineightclinicaltrialsofadultsandadolescents(aged12yearsorolder)withasthmaandexercise-inducedbronchospasm,thecompanynotes.Adverseeventswereconsistentwiththoseseenwithpreviousalbuterolinhalers.
Themostcommonadverseeventsseenin>1%ofpatientstreatedwithProAirRespiClickcomparedwithplacebowerebackpain,bodyachesandpains,upsetstomach,sinusheadache,andurinarytractinfection.
医药网新闻