Aptalis Pharma用于治疗囊性纤维化伴慢性铜绿假单胞菌感染的孤儿药 Quinsair （左氧氟沙星）
通用名：左氧氟沙星
商品名称：Aeroquin，Quinsair（EU）
别名：MP-376
输入类型：新配方
主治：用于治疗由于绿脓杆菌在成年患者的囊性纤维化的慢性肺部感染
| Name | Quinsair |
|---|---|
| INN or common name |
levofloxacin |
| Therapeutic area | Respiratory Tract InfectionsCystic Fibrosis |
| Active substance |
levofloxacin |
| Date opinion adopted | 18/12/2014 |
| Company name |
Aptalis Pharma SAS. |
| Status | Positive |
| Application type | Initial authorisation |
| Name | Language | First published | Last updated |
|---|---|---|---|
| CHMP summary of positive opinion for Quinsair |
Information
Generic Name: levofloxacin
Trade Name: Aeroquin, Quinsair (EU)
Synonym: MP-376
Entry Type: New formulation
Development and Regulatory status
UK: Recommended for approval (Positive opinion)
EU: Recommended for approval (Positive opinion)
US: Phase III Clinical Trials
UK launch Plans: Available only to registered users
Actual UK launch date:
Comments
Dec 14: EU positive opinion for treatment of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis [8].
19/12/2014 12:46:50
Jan 14: Filed in the EU [7].
04/02/2014 10:11:18
Orphan status in EU and US granted 2008 [5], [6].
05/04/2013 12:17:30
Apr 13: Open-label extension study vs. tobramycin is due to complete Jun 2013 - NCT01270347 [4].
05/04/2013 12:00:17
Apr 11: PIII trials due for completion May/June 2011 [2].
21/04/2011 15:30:35
Jan 11: PIII study vs tobramycin started [1].
11/01/2011 10:27:33
Trial or other data
Jan 13: In Study 209 (n=282), nebulised levofloxacin 240mg BD was compared to nebulised tobramycin in a randomised, open-label, three 28-day on/off treatment cycles. The primary endpoint -- non-inferiority of relative change from baseline in percent predicted Forced Expiratory Volume in 1 Second (FEV1) after the first treatment cycle of 28 days -- was met. This effect with Aeroquin on lung function was maintained over all three treatment cycles (i.e., through Day 168). For other clinically relevant secondary endpoints, such as quality-of-life measures and time to pulmonary exacerbation, the effect of Aeroquin was measurably similar or superior to TIS. An open-label extension study of Study 209 is ongoing. Tolerability and safety of Aeroquin was similar to tobramycin, but dysgeusia occurred more frequently with Aeroquin due to the metallic taste of levofloxacin. [3]
08/01/2013 09:48:39
Jan 13: Results of two Phase 3 studies of Aeroquin in pts with CF with stable chronic lung infection with Pseudomonas aeruginosa (Studies 207 and 209). In Study 207 (n=330), nebulised levofloxacin 240mg BD was compared to placebo in a double-blind, randomised, single treatment cycle of 28 days. The differences between Aeroquin and placebo groups in the predefined primary endpoint of time to first pulmonary exacerbation were not statistically significant, however efficacy among certain secondary endpoints (lung function, reduction in Pseudomonas aeruginosa from sputum) in Aeroquin treated patients was demonstrated. Tolerability and safety of Aeroquin was similar to placebo, but dysgeusia occurred more frequently with Aeroquin due to the metallic taste of levofloxacin. [3]
08/01/2013 09:48:31
Jan 11: NCT01270347 is a PIII, open-label, randomized trial evaluating the safety and efficacy of levofloxin inhalation solution (Aeroquin) vs. tobramycin inhalation solution in 267 stable CF patients. Levofloxacin and tobramycin will be administered twice daily over 3 consecutive cycles of 28-days treatment followed by 28 days off treatment. Primary outcomes are safety over 168 days and efficacy measured by% change in percent predicted FEV1 from baseline to day 28. The study started in Jan 11 and is due to complete Jun 12 [1].
11/01/2011 10:22:38
References
Available only to registered users
Category
BNF Category: Quinolones (05.01.12)
Pharmacology: Inhibitor of DNA gyrase and DNA topoisomerase IV
Epidemiology: Prevalence is 1 in 2,500 newborn, with calculated carrier frequency of 1 in 25. Over 9,000 people currently have CF in the UK
Indication: Cystic fibrosis
Additional Details: associated Pseudomonas aeruginosa infections
Method(s) of Administration
Inhalation
Company Information
Name: Forest Labs
US Name: Aptalis
Further Information
Anticipated Commissioning route (England) -
In timetable: -
PbR Awaiting Update