2017年12月5日,美国食品药品监督管理局(FDA)已经批准格隆溴铵吸入溶液(25微克,两次/天)Sunovion Pharmaceuticals(商标名:Lonhala Magnair),也称SUN-101/eFlow®,用于维持治疗慢性阻塞性肺病(COPD)成人气流阻塞,包括慢性支气管炎和/或肺气肿。
Lonhala Magnair是FDA批准用于治疗COPD的第一种雾化长效毒蕈碱拮抗剂(LAMA)。Sunovion在新闻稿中表示,这是PARI Pharma GmbH开发的Magnair eFlow技术系统被首次使用。
格隆溴铵 该公司表示:“这项技术是一种几乎无声的,便携式的封闭系统雾化器,设计用于在两到三分钟内递送药物,并允许人们在使用该设备时正常呼吸。 “尽管有几种治疗方法可供选择,但很多人仍然很难控制其COPD—这种挑战可能受到给药方法的影响,”Farmington Hills东南密歇根州肺部研究所的Gary Ferguson博士在发布中表示。
Lonhala Magnair “Lonhala Magnair 提供了一个重要的新选择,它结合了经过验证的COPD药物的疗效和独特的手持式雾化器的特性,使人们在用药时能够正常呼吸。”Ferguson博士说。
该批准基于GOLDEN(通过电子雾化器治疗阻塞性肺病的格隆溴铵)项目的临床试验数据,其中包括中度至极重度COPD成人受试者,GOLDEN-3和GOLDEN-4两项随机、双盲、安慰剂对照研究。 在这些研究中,该公司表示,使用Lonhala Magnair的受试者在第12周时,其最大呼气第一秒呼出的气量的容积(FEV1)显示出与基线相比具有统计学显着性差异和临床意义。 此外,GOLDEN-5第3期研究显示了Lonhala Magnair与通过HandiHaler装置递送的噻托溴铵,在中度至极重度COPD成人中相比的长期安全性和耐受性。 总体而言,在48周内接受格隆溴铵和接受噻托溴铵治疗的患者的治疗紧急不良事件相似。 Lonhala Magnair(glycopyrrolate) Inhalation Solution (25mcg twice daily) LONHALA MAGNAIR Rx Generic Name and Formulations: Cholera vaccine, live attenuated (V. cholerae strain CVD 103-HgR); 100mL per single dose; susp for oral administration after reconstitution. Company: PaxVax Corporation Select therapeutic use: Vaccines Indications for VAXCHORA: Immunization against disease caused by Vibrio cholerae serogroup 01 in adults 18–64 years of age traveling to cholera-affected areas. Limitations Of use: Efficacy not established in persons living in cholera-affected areas or persons with pre-existing immunity due to previous exposure to V. cholerae or receipt of a cholera vaccine. Not shown to protect against disease caused by V. cholerae serogroup 0139 or other non-01 serogroups. Adult: For oral administration only. Avoid food or drink for 60mins before and after administration. ≥18yrs: Give single oral dose a minimum of 10 days before potential cholera exposure. Children: <18yrs: not established. Contraindications: Severe allergic reaction to any previous cholera vaccine. Warnings/Precautions: Immunocompromised. Considering whether to administer to individuals with immunocompromised close contacts. Elderly. Pregnancy. Interactions: Avoid use within 14 days of systemic antibiotics. Give vaccine ≥10 days prior to antimalarial prophylaxis with chloroquine. Concomitant immunosuppressive therapy (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, high-dose corticosteroids): may get suboptimal response. Pharmacological Class: Cholera vaccine. Adverse Reactions: Tiredness, headache, abdominal pain, nausea/vomiting, lack of appetite, diarrhea. Note: To enroll patients in the pregnancy exposure registry call (800) 533-5899. Generic Availability: NO How Supplied: Single-dose carton—2 packets (buffer component + active component)
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