资讯中心

FDA批准粉尘螨舌下免疫治疗新药

FDA approves sublingual immunotherapy for dust mite allergies
来源:Frontline Medical News 2017-03-21 10:43点击次数:10417发表评论


FDA近日批准一种用于治疗粉尘螨所致鼻腔炎症的舌下免疫治疗药物。


The Food and Drug administration has approved a sublingual immunotherapy to treat nasal inflammation caused by dust mite allergy.


Odactra(默沙东公司)获准用于年龄介于18~65岁伴或不伴结膜炎的过敏性鼻炎成人患者。FDA在3月1日发布的声明中指出,该片剂提供了皮下注射剂之外的另一种选择。


Odactra (Merck, Sharp & Dohme) had been approved in adults aged 18-65 years, with allergic rhinitis with or without conjunctivitis. The tablets offer an alternative to subcutaneous injections, the FDA said in a statement issued March 1.


据FDA称,该舌下片需全年每天服用,首次服用应在医师监督下进行,以监测不良反应。与其他舌下免疫治疗药物一样,服用该片剂的患者应同时开具肾上腺素自动注射剂。


The sublingual tablets are intended to be taken daily, year-round, and the first dose must be taken under physician supervision to monitor for adverse reactions, according to the FDA. As with other sublingual immunotherapies, patients using the tablets should be simultaneously prescribed autoinjectable epinephrine.


据FDA称,该批准是基于在欧洲和美国开展的纳入约2500例患者的随机试验结果。与安慰剂相比,服用该药物的患者症状下降16%~18%。临床获益可能在开始治疗后的8~14周显现。研究期间报告的常见不良反应包括恶心、耳部和口部瘙痒,以及唇部和舌部水肿。


The approval was based on results from randomized trials enrolling about 2,500 patients in Europe and the United States, according to the FDA. Patients taking the tablets saw a 16%-18% reduction in symptoms across studies, compared with placebo. Clinical benefit may be delayed by 8-14 weeks after starting the therapy, the agency said. Common adverse reactions reported in the studies included nausea, itching of the ears and mouth, and swelling of the lips and tongue.


Odactra是自2014年以来在美国获批的第4个舌下免疫治疗药物。其他获批的药物针对草和豚草过敏。


Odactra is the fourth sublingual immunotherapy to be approved in the United States since 2014. Other approved therapies target grass and ragweed allergies.


独家授权,未经许可请勿转载!


---------------------------------------------------------------------------------------------------------------------------------------------
欢迎关注Elseviermed官方微信
学科代码: 呼吸病学  变态反应、哮喘病与免疫学     关键词:Odactra 屋尘螨 FDA ,新闻 爱思唯尔医学网, Elseviermed
来源: Frontline Medical News
顶一下(0
您可能感兴趣的文章
发表评论网友评论(0)
发表评论
登录后方可发表评论,点击此处登录
他们推荐了的文章