梯瓦新药DuoResp Spiromax获欧盟批准用于COPD和哮喘

关键词:梯瓦,慢性阻塞性肺病,哮喘,DuoResp Spiromax,吸入性皮质类固醇,LABA

2014年5月1日讯 /生物谷BIOON/ --梯瓦(Teva)4月29日宣布,药物DuoResp Spiromax获欧盟委员会(EC)批准,用于适合糖皮质激素和长效β2-肾上腺素受体激动剂组合疗法的慢性阻塞性肺病(COPD)和哮喘(asthma)患者的治疗。

DuoResp Spiromax(budesonide & formoterol fumarate dihydrate,布地奈德+福莫特罗富马酸盐二水合物)是一种新的多剂量干粉吸入剂,由布地奈德(budesonide)和福莫特罗(formoterol)组成。布地奈德是一种吸入性皮质类固醇(ICS),用于治疗哮喘患者和COPD患者潜在的炎症;福莫特罗是一种速效和长效β2激动剂(LABA),用于缓解哮喘患者和COPD患者的支气管收缩(bronchoconstriction )。Spiromax吸入器采用独特的呼吸驱动技术,能够递送一致剂量的药物。

DuoResp Spiromax的开发,旨在改善药物的易用性,并递送一致剂量的药物。由于吸入器技术的落后,许多哮喘和COPD患者存在治疗不足(under-treated)的情况,这导致了额外的就诊次数以及需要紧急护理等形式的不必要负担。

DuoResp Spiromax将进入吸入性皮质类固醇/长效β2激动剂(ICS/LABA)固定剂量组合吸入剂细分市场,在全球范围内,ICS/LABA药物销售额达139亿美元,欧洲市场销售额达44亿美元。(生物谷Bioon.com)

英文原文:Teva Receives European Marketing Authorization for DuoResp Spiromax? for the Treatment of Asthma and COPD

JERUSALEM--(BUSINESS WIRE)--Apr. 29, 2014-- Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) announced today that the European Commission has granted marketing authorization for DuoResp Spiromax? for the treatment of patients with asthma and chronic obstructive pulmonary disease (COPD) where the use of a combination of an inhaled corticosteroid and long-acting beta2-adrenoceptor agonist is appropriate.

DuoResp Spiromax? is a new, multi-dose dry-powder inhaler containing a Fixed Dose Combination (FDC) of budesonide, an inhaled corticosteroid to treat the underlying inflammation in asthma and COPD, and formoterol fumarate dihydrate, a rapid-acting and long-lasting beta2 agonist for the relief of bronchoconstriction in asthma and COPD.

“We are delighted to receive approval for DuoResp Spiromax?,” said Rob Koremans, M.D., President and CEO, Teva Global Specialty Medicines. “This is a major advance in inhalers – the need for more intuitive devices is critical and has been highlighted by healthcare professionals and patient groups. It is widely accepted that poor or inadequate inhaler technique not only negatively impacts treatment adherence, but means that patients do not obtain the full benefit from their medication.”

Koremans added, “We are extremely proud of Spiromax. Our innovative approach to the development of the product means that it offers the key features required for an ideal inhaler. DuoResp Spiromax? provides a valuable addition to currently available inhalation devices for the treatment of asthma and COPD. It is the first and important milestone in the rollout of our Respiratory portfolio in Europe.”

DuoResp Spiromax? has been demonstrated to be therapeutically equivalent to the well-established budesonide/formoterol combination. The Spiromax inhaler uses a unique technology to deliver a consistent, effective and accurate dose.

Inhaled therapy with fixed dose combinations of inhaled corticosteroids and long-acting beta-agonists is an important step in achieving good asthma and COPD control. However a substantial percentage of users of inhalers worldwide have inadequate inhaler technique and increased inhalation errors.

The Spiromax inhaler has been designed by looking at patient inhalation challenges not in terms of human error, but as a design problem to be solved. The result is an inhaler designed to improve ease of use and consistent delivery from the first to the last dose with three simple steps: open, breathe and close. Furthermore, it confirms to patients that a dose has been taken through a taste of lactose and a clear dose indicator.

Two Phase III trials in patients with persistent asthma are ongoing in Europe to compare the benefits of DuoResp Spiromax and a budesonide/formoterol multi-dose dry powder inhaler. Both studies are expected to report out in 2014.

About Asthma and COPD

30 million people in Europe are living with asthma, with an estimated 82,000 hospital admissions each year costing some 33.9 billion. COPD affects 23 million people in Europe, resulting in 1.1 million hospital admissions annually and estimated indirect and direct costs of 48.4 billion.

(责任编辑:lishuheng)

小编提示:87%用户都在生物谷APP上阅读,扫描立刻下载!

您还可以这样阅读

微信扫一扫,体验新式阅读

打开微信扫描二维码

生物谷微信账号:bioonnews

我们提供多种阅读途径供您选择,随时随地掌握医药生物领域最新资讯。

生物谷微信二维码

    相关资料

    欢迎行业评论、发现、小道消息、官方爆料、采访约稿

    我要投稿   下载App支持编辑