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AstraZeneca's three-drug inhaler Breztri Aerosphere has shown efficacy for uncontrolled asthma in a pair of phase 3 trials that could extend its label beyond the drug's current use in chronic obstructive pulmonary disease (COPD).
阿斯利康的三联药物吸入器Breztri Aerosphere在两项三期试验中显示出对未受控制的哮喘的有效性,这可能使其适应症扩展到该药物目前在慢性阻塞性肺病(COPD)中的应用之外。
In the KALOS and LOGO studies, Breztri (budesonide/glycopyrronium/formoterol fumarate) – known as Trixeo in some markets – achieved 'a statistically significant and clinically meaningful improvement in lung function' compared to dual-drug therapies based on inhaled corticosteroids (ICS) and long-acting beta agonists (LABA), according to AZ..
在KALOS和LOGO研究中,阿斯利康表示,与基于吸入性皮质类固醇(ICS)和长效β激动剂(LABA)的双药疗法相比,Breztri(布地奈德/格隆溴铵/富马酸福莫特罗)——在某些市场称为Trixeo——实现了“在肺功能上具有统计学显著性和临床意义的改善”。
Breztri layers in umeclidinium, a long-acting muscarinic antagonist (LAMA), to the ICS/LABA combination of budesonide and formoterol fumarate.
Breztri 在布地奈德和富马酸福莫特罗的 ICS/LABA 组合中加入了长效毒蕈碱拮抗剂 (LAMA) umeclidinium。
The company said it plans to submit the new data for regulatory review, and approval could add considerable momentum to Breztri, which is already knocking on the door of blockbuster status with sales up 44% to $978 million last year and with more than 5.5 million people worldwide prescribed the drug..
该公司表示,计划将新数据提交监管审查,而获得批准可能会为布雷兹里(Breztri)增添可观的推动力。布雷兹里去年销售额增长了44%,达到9.78亿美元,全球已有超过550万人被开具该药物,已经接近重磅炸弹药物的地位。
It was approved by the FDA as a treatment for COPD in 2020 and, according to GlobalData estimates, extending its label to include uncontrolled asthma could clear the way for sales to climb to more than $2.3 billion by 2030.
它在2020年被FDA批准用于治疗慢性阻塞性肺病,根据GlobalData的估计,将其适应症扩展到包括不受控制的哮喘,可能会使销售额到2030年攀升至超过23亿美元。
As many as 262 million people worldwide are affected by asthma, and it is estimated that nearly half of those treated with dual therapy remain uncontrolled, which can significantly limit lung function and decrease quality of life, said AZ in a statement.
阿斯利康在一份声明中表示,全球有多达 2.62 亿人受到哮喘的影响,据估计,其中近一半接受双重疗法治疗的患者仍未得到控制,这可能会显著限制肺功能并降低生活质量。
Breztri is one of the medicines at the heart of AZ's growth aspirations in respiratory diseases along with IL-5 inhibitor Fasenra (benralizumab) and TSLP inhibitor Tezspire (tezepelumab), which are both approved for severe asthma indications and are also being developed for COPD. Last year, AZ also reported new data on Fasenra in .
Breztri 是阿斯利康(AZ)在呼吸系统疾病增长计划中的核心药物之一,与 IL-5 抑制剂 Fasenra(benralizumab)和 TSLP 抑制剂 Tezspire(tezepelumab)并列,后两者均已获批用于重度哮喘适应症,并且也正在开发用于慢性阻塞性肺病(COPD)。去年,阿斯利康还报告了有关 Fasenra 的新数据。
acute asthma
急性哮喘
that it called the first major advance for this aspect of the disease in 50 years.
这是该疾病领域在50年里的首次重大进展。
Respiratory is a key part of AZ's ambitious target of swelling group revenues to more than $80 billion in 2030 from a 2024 level of just over $54 billion. The company has high hopes for Breztri, suggesting it could generate $3 to $5 billion at its peak.
呼吸系统是阿斯利康(AZ)实现宏伟目标的关键部分,即到2030年将集团收入从2024年的略高于540亿美元提升至超过800亿美元。公司对Breztri寄予厚望,认为其在巅峰时期可能创造30亿至50亿美元的收入。
Full results from KALOS and LOGOS will be presented at an upcoming medical meeting.
KALOS 和 LOGOS 的完整结果将在即将召开的医学会议上公布。
'These asthma data build on the well-established profile of Breztri in COPD, and we look forward to sharing with regulatory authorities to bring this important medicine to a wider group of patients,' said AZ's head of biopharma R&D Sharon Barr.
阿斯利康生物制药研发主管莎伦·巴尔表示:“这些哮喘数据进一步完善了Breztri在慢阻肺病(COPD)中已确立的特性,我们期待与监管机构分享,以将这一重要药物带给更广泛的患者群体。”
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