CHMP建议批准梯瓦COPD和哮喘药DuoResp Spiromax

关键词:梯瓦,哮喘,COPD,DuoResp Spiromax,布地奈德,福莫特罗

2014年2月22日讯 /生物谷BIOON/ --梯瓦(Teva)2月21日宣布,药物DuoResp Spiromax获得了欧洲药品管理局(EMA)人用医药产品委员会(CHMP)的积极意见。CHMP建议批准DuoResp Spiromax,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。欧盟委员会(EC)预计将在几个月内做出最终审查决定。

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

英文原文:Teva Receives CHMP Positive Opinion for DuoResp? Spiromax? for the Treatment of Patients Diagnosed with Asthma and COPD in Europe

Innovative new inhaler for asthma and COPD patients

JERUSALEM--(BUSINESS WIRE)--Feb. 21, 2014-- Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for DuoResp? Spiromax? (budesonide & formoterol fumarate dihydrate) inhalation powder for the treatment of patients with asthma and chronic obstructive pulmonary disease (COPD) when a combination inhaled corticosteroid and long-acting beta2-adrenoceptor agonist is appropriate. This CHMP decision creates a path forward for a final approval decision from the European Commission that is expected in the next few months.

DuoResp? Spiromax? is a new multi-dose dry-powder inhaler with a combination 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. The Spiromax? inhaler uses unique breath-actuated technology to deliver a consistent dose of the medicines from the first dose to the last.

DuoResp? Spiromax? was developed to improve ease of use and provide consistent delivery of medicine to patients. Many patients with asthma and COPD are under-treated as a consequence of poor inhaler technique. This leads to unnecessary burden in the form of additional clinic visits and need for emergency care. DuoResp? Spiromax? will enter the ICS/LABA fixed combination inhaled market segment that has total product sales of $13.9B USD worldwide, and $4.4B USD within Europe.

“We have planned for strong growth in Respiratory,” said Michael Hayden, President, Global R&D and Chief Scientific Officer, “The Spiromax? inhaler is an important addition to our Respiratory portfolio and supports our strategy to become a leading presence in Respiratory with a robust and differentiated pipeline, projected to be a multi-billion dollar franchise by the end of the decade.”

In addition to the European application, applications will be made in a number of major countries worldwide.

“The Committee’s favorable view of the registration dossier for DuoResp? Spiromax? marks an important step in Teva’s journey to deliver a valuable new treatment option for the treatment of patients with asthma and COPD,” said Rob Koremans, M.D., President and CEO, Teva Global Specialty Medicines. “We look forward to receiving the final decision from the European Commission.”

Two late stage trials in patients with persistent asthma are currently ongoing to compare the benefits of DuoResp? Spiromax? vs Budesonide/Formoterol Multi-dose Dry Powder Inhaler. Both studies are expected to report in 2014 but are not required to be completed to gain final approval from the European Commission.

COPD affects 23 million people in Europe resulting in 1.1 million hospital admissions annually (estimated indirect and direct cost, 48.4bn.)

ASTHMA: 30 million people across Europe are living with asthma with an estimated 82,000 hospital admissions each year costing some 33.9bn.











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