繁体中文
设为首页
加入收藏
当前位置:药品说明书与价格首页 >> 抗感染类 >> 新药动态 >> FDA批准TOBI Podhaler治疗囊性纤维化引起的细菌性肺感染

FDA批准TOBI Podhaler治疗囊性纤维化引起的细菌性肺感染

2013-03-23 14:34:45  作者:新特药房  来源:互联网  浏览次数:83  文字大小:【】【】【
简介:2013年3月22日美国食品和药品监督管理局批准TOBI Podhaler(妥布霉素吸入粉tobramycin inhalation powder)为处置有铜绿假单胞菌[Pseudomonas aeruginosa],一种致肺感染细菌囊性纤维化患者。囊性纤维化是一种遗传 ...

2013年3月22日美国食品和药品监督管理局批准TOBI Podhaler(妥布霉素吸入粉tobramycin inhalation powder)为处置有铜绿假单胞菌[Pseudomonas aeruginosa],一种致肺感染细菌囊性纤维化患者。
囊性纤维化是一种遗传疾病在美国约影响30,000儿童和成年患者。囊性纤维化致机体产生肺中生成的粘稠的粘液和阻塞气道。生成的粘液使细菌像铜绿假单胞菌容易生长和引起慢性肺部感染,随时间可严重损害肺。有囊性纤维化许多患者用抗菌素雾化器治疗。
TOBI Podhaler,一种塑料,手持吸入装置,含干妥布霉素粉制剂,一种抗菌素用于治疗铜绿假单胞菌感染。用Podhaler装置每天吸入粉2次共28天。然后在再次恢复治疗前患者应停用TOBI Podhaler治疗28 天。
FDA的药物评价和研究中心抗微生物产品室主任Edward Cox,M.D.,M.P.H说:“今天的批准对有囊性纤维化需要治疗铜绿假单胞菌患者扩大可得到的输送机制的选择,”“这是第一个手持干粉吸入器输送干粉抗细菌药物产品。”
在 一项95例有囊性纤维化儿童和成年患者研究确定TOBI Podhaler的有效性。所有患者是6 岁或以上和被铜绿假单胞菌感染。患者在研究的第一个28天被随机赋予接受TOBI Podhaler或一种安慰剂。然后研究剩余所有患者接受接受TOBI Podhaler治疗。
研究被设计通过测量在一秒钟用力呼气量(FEV1)变化确定肺功能的改善。用TOBI Podhaler治疗患者经历FEV1统计显著增加12.5 %与之计较用安慰剂治疗患者为0.09 %。从另外纳入的487例患者研究的另外数据支持安全性和有效性。
在临床研究期间用TOBI Podhaler治疗患者报告单常见副作用包括咳嗽,产生痰或粘液的咳嗽;咳血(咯血);肺疾病;气短;发热;口和喉痛;音量或质变化(发声困难);和头痛。
TOBI Podhaler由总部设在新泽西州的东汉诺威诺华公司上市。

Inhaled Medications
Inhaled medications are delivered with a nebulizer or puff (dry powder inhalator) in a mist of tiny droplets directly to the lungs, fostering penetration into the lungs.
Inhaled drugs are commonly used in cystic fibrosis care because they reach the airways quickly and easily. Inhaled treatments can be given by aerosol—a mist made from liquid medicines. The medicines go into a cup (nebulizer) that is attached to a small air compressor. The compressor blows air through the cup and makes a mist. People with cystic fibrosis breathe the mist in through a mouthpiece (or mask for infants and young children) for several minutes. Some medicines can also be given as metered dose inhalers (MDI, puff  or dry powder inhalator) which deliver one dose of medicine at a time.
There are several kinds of inhaled medications used to treat CF symptoms:
Mucolytics like Pulmozyme® to thin mucus so people can cough it out easier.
Antibiotics to treat infections.
Inhaled TOBI®  (tobramycin solution for inhalation) is a widely used antibiotic treatment. TOBI can be effective against the most common source of chronic lung infections, a bacterium called Pseudomonas aeruginosa. TOBI® nebulized solution is the most widely used form of tobramycin. It is indicated for the treatment of chronic Pseudomonas aeruginosa (Pa) lung infections in adults and children aged six years and older with cystic fibrosis (CF). TOBI®  vials need to be refrigerated and are administered with a nebulizer device which require electricity, cleaning and disinfection after treatment.
TIP® (TOBI® podhaler®) is a new dry powder formulation of tobramycin delivered in less than 2mn with a convenient, portable, easy-to-use breath-activated device that does not require a power supply. TOBI® Podhaler® is now approved in EU, Canada, Chile & Colombia and under review in many more countries. TOBI®  Podhaler®  is indicated for the treatment of chronic Pseudomonas aeruginosa (Pa) lung infections in adults and children aged six years and older with cystic fibrosis (CF).
o   Cayston® nebulized solution is a new form of aztreonam. It is indicated in EU for the suppressive therapy of chronic pulmonary infections due to Pa in patients with CF aged 18 years and older and in the USA, Cayston®  is indicated to improve respiratory symptoms in CF patients with Pa. Safety and effectiveness have not been established in pediatric patients below the age of 7 years. Cayston®  vials need to be refrigerated and are administered with a nebulizer device which require electricity, cleaning and disinfection after treatment.

Hypertonic saline, a solution of salt and water,  to draw more water into the airways and make it easier to cough out the mucus. Hypertonic saline as an inhaled therapy is believed to increase hydration of airway surface liquid in people with CF, thereby improving mucociliary clearance. A Phase 3 trial conducted in Australia had beneficial effects on pulmonary health in people with CF aged 6 years and older. Hypertonic saline is currently being used worldwide by a large number of people with CF. Additional clinical trials to determine safety and effectiveness in infants and children less than 4 years of age will be completed near the end of 2011.
Bronchitol: Bronchitol is an inhaled dry powder form of mannitol (an osmotic sugar) that is thought to help rehydrate CF secretions, thereby improving airway clearance. Bronchitol has completed two large multinational Phase 3 trials. It is approved for the treatment of CF in Australia and was submitted to the American FDA in 2011. In Europe Bronchitol is only taken by patients participating in clincal trials and no market authorisation has been obtained yet.

责任编辑:admin


相关文章
KALYDECO(IVACAFTOR tablets)
依伐卡托片|Kalydeco(ivacaftor tablets)
欧洲快速审批Kalydeco(ivacaftor)上市
妥布霉素注射液Nebcin(Tobramycin Injection)
妥布霉素吸入粉剂(TIP)用于治疗与囊性纤维化的肺部感染
氨曲南吸入液Cayston(aztreonam)
Kalydeco(ivacaftor)片
美国FDA批准Kalydeco(ivacaftor)治疗囊性纤维化
ZAVESCA(美格鲁特胶囊,MIGLUSTAT)
美格鲁特胶囊(zavesca)-全球首例治疗高雪病的药物
 

最新文章

更多

· 美国FDA批准Avelox对瘟疫...
· FDA批准Anthrasil治疗吸...
· ZINFORO INFUSION(CONC...
· 新抗真菌药Cresemba(艾沙...
· 新类抗菌药Avycaz(cefta...
· Quinsair(MP-376,左氧...
· 新剂型Noxafil(posacon...
· 新型抗菌药ZERBAXA(ceft...
· 外耳道炎新药Xtoro(fin...
· Isavuconazole(艾沙康唑...

推荐文章

更多

· 美国FDA批准Avelox对瘟疫...
· FDA批准Anthrasil治疗吸...
· ZINFORO INFUSION(CONC...
· 新抗真菌药Cresemba(艾沙...
· 新类抗菌药Avycaz(cefta...
· Quinsair(MP-376,左氧...
· 新剂型Noxafil(posacon...
· 新型抗菌药ZERBAXA(ceft...
· 外耳道炎新药Xtoro(fin...
· Isavuconazole(艾沙康唑...

热点文章

更多