新药研发前沿动态 / 医药领域趋势进展

Spotlight on Drugs of Chronic Obstructive Pulmonary Disease
中文关键词:  慢性阻塞性肺病  药品生命周期  长效β 受体激动剂  长效毒蕈碱拮抗剂  吸入型皮质类固醇
英文关键词:chronic obstructive pulmonary disease  lifecycle management  long-acting beta-agonists (LABA)  long-acting beta-agonists (LABA)  the inhaled corticosteroid (ICS)
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      慢性阻塞性肺病(COPD) 是肺部进行性疾病,需长期治疗。预计到2020 年,每年COPD 将会导致全球600 多万人死亡。尽管对新型药物开发投资不断增加,但该领域的治疗仍以缓解症状的支气管扩张吸入剂为主,而不是治愈性疗法,故应对COPD 的创新药的研发仍困难重重。与乳腺癌等疾病领域相比,呼吸系统药物的研发成功率不到50%,但每种获批药物的研发成本却翻倍。因此,制药公司致力于药品生命周期的管理,在当前治疗的基础上进一步改进。其策略包括不同种类药物联用、开发新配方和各种剂量剂型,改善疗效,方便给药。其中以长效β 受体激动剂 (LABA)/ 长效毒蕈碱拮抗剂(LAMA) 的定量复方药的需求增长最多。领导市场的GSK 公司的LABA 沙美特罗和吸入型皮质类固醇 (ICS) 氟替卡松的复方药Advair,就是应用以上方法的典型。虽已出现潜在新型靶标,但这些药物还处于早期开发阶段。吸入型LABA/ICS 定量复方药短期内仍是 COPD 治疗领域的主力军。
      Chronic obstructive pulmonary disease (COPD) is a progressive disease of the lungs that requires lifelong treatment. By 2020, COPD is predicted to account for more than 6 million deaths worldwide each year. Despite investment in the development of novel agents to treat the disease, the COPD therapy area is dominated by inhaled bronchodilator therapies that relieve symptoms, but are not curative. Innovation in COPD is challenging. Respiratory medicines have less than a 50 percent success rate compared with disease areas such as breast cancer, but are twice as expensive in terms of capitalized cost per an approved drug. As a result, pharmaceutical companies have focused their efforts on lifecycle management to provide incremental improvements over current therapies. Strategies include combining drugs from different classes and novel formulations and doses for improved efficacy and patient convenience. Fixed-dose combinations that include long-acting beta-agonists (LABA)/longacting muscarinic antagonists (LAMA) are driving the greatest growth. This approach is typified by GSK’s market-leading Advair, a combination of the LABA salmeterol and the inhaled corticosteroid (ICS) fluticasone. While potentially novel targets are beginning to emerge, such agents are in the early stages of development. In the near-term, inhaled fixed-dose LABA/ICS combinations are set to remain the leading class within the COPD therapy area.
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