2013年9月22日,诺华(Novartis)和Vectura制药宣布,慢性阻塞性肺病(COPD)新药Ultibro(glycopyrronium/indacaterol,格隆/马来酸茚达特罗,50mcg/110mcg)获日本劳动卫生福利部(MHLW)批准,作为每日一次的吸入性胶囊,用于缓解COPD患者气道阻塞所致的各种症状。该药有望成为COPD临床护理的新标准,并有望使诺华取代葛兰素史克(GSK)在COPD市场中的领导地位。
Ultibro吸入性胶囊是实验性药物QVA149的商品名,通过Breezhaler单剂量干粉吸入器给药,是诺华公司在其Breezhaler吸入器中的第三个创新药物。
QVA149(格隆/马来酸茚达特罗,50mcg/110mcg)是一种具双重作用模式的支气管扩张剂,结合了诺华2种COPD药物的疗效和安全性:Onbrez吸入性胶囊(indacaterol,LABA)和Seebri吸入性胶囊(glycopyrronium,LAMA),这2种药物均通过Breezhaler单剂量干粉吸入器给药。目前,Onbrez和Seebri已在包括日本在内的多个国家广泛使用。
今年4月,诺华公布了有关QVA149在慢性阻塞性肺病(COPD)患者中的III期SPARK研究的详细结果。研究表明,与格隆(50mcg)及噻托溴铵(18mcg)相比,QVA149能够更有效地减少COPD急性发作。该项研究首次将固定剂量的长效β2-受体激动剂(LABA)和长效毒蕈碱受体拮抗剂(LAMA)组合与单一的LAMA疗法进行疗效比较。
Ultibro inhalation capsules cleared in Japan for the treatment of COPD
UK developer of inhaled therapies Vectura confirmed that the MHLW approved Swiss drug major Novartis’ (NOVN: VX) once-daily Ultibro inhalation capsules (glycopyrronium 50mcg/indacaterol 110mcg), delivered through the Breezhaler device, for relief of various symptoms due to airway obstruction in chronic obstructive pulmonary disease (COPD). Ultibro Inhalation Capsules were developed under the name of QVA149 and will be available to the 5.3 million Japanese patients who may be living with COPD. The approval triggers a £2.5 million milestone for Vectura.
Dual bronchodilation with QVA149 is expected to set a new standard of care in COPD by combining the proven efficacy and safety benefits of two established Novartis COPD treatments; the LABA, Onbrez inhalation capsules (indacaterol), and the LAMA, Seebri inhalation capsules (glycopyrronium bromide). Both these components are delivered through the Breezhaler device, as is QVA149, and are widely available in many countries around the world including Japan.