2014年11月26日，慢性阻塞性肺病(COPD)复方新药Duaklir Genuair(阿地溴铵/富马酸福莫特罗，340/12 mcg)获得欧盟批准，用作一种维持性支气管扩张剂，以减轻COPD成人患者的疾病症状。
Duaklir Genuair是由2种已上市的长效支气管扩张剂组成的固定剂量复方药物，其中，bromide(阿地溴铵)是一种新颖的长效毒蕈碱拮抗剂(LAMA)，formoterol fumarate(富马酸福莫特罗)是一种长效β2受体激动剂(LABA)。Duaklir Genuair通过干粉吸入器Genuair给药，每日2次，是首个与单药相比使呼吸喘促表现出统计学意义显著改善的LAMA/LABA复方药。
据估计，目前全球范围内大约有3亿慢性阻塞性肺病(COPD)患者，改善肺功能及管理日常症状(如喘促气短)对于COPD的临床管理非常重要。
aclidinium bromide/formoterol fumarate dihydrate (Duaklir Genuair)阿地溴铵/福莫特罗富马酸盐
Forthcoming Submission: aclidinium bromide/formoterol fumarate dihydrate (Duaklir Genuair)
Indication: as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Drug Details
Drug Name: aclidinium bromide/formoterol fumarate dihydrate (Duaklir Genuair)
Drug Manufacturer: Almirall Ltd
Generic Name: aclidinium bromide + formoterol fumarate
Trade Name: Duaklir Genuair (EU)
Synonym: Brimica Genuair
Entry Type: New formulation
Developmental Status
UK: Approved (Licensed)
EU: Approved (Licensed)
US: Phase III Clinical Trials
UK launch Plans: Available only to registered users
Actual UK launch date:
Comments
Nov 14: Approved in the EU [10].
27/11/2014 16:14:50
Sep 14: EU positive opinion for use as maintenance bronchodilator treatment for airflow obstruction and relief of symptoms in adult patients with COPD [9].
29/09/2014 11:49:44
Nov 13: Filed in the Eu for the treatment of COPD [8].
06/11/2013 08:20:50
Aug 13: Company are delaying filing in the US after the FDA raised issues related to "chemistry, manufacturing and control specifications associated with the combination formulation" [7].
15/08/2013 19:12:24
May 13: Regulatory filings in the EU and US planned for Q4 2013 [5].
03/05/2013 09:05:40
Sep 11: PIII studies started [1].
27/09/2011 09:11:53
Trial or other data
Jul 13: NCT01908140 is a randomised, double-blind, double-dummy, active-controlled study eva luating the efficacy, safety and tolerability of twice-daily aclidinium bromide/formoterol fumarate (400/12mcg) vs twice-daily salmeterol/fluticasone propionate (50/500mcg) for 24 weeks treatment in 900 symptomatic patients with COPD. The study starts Sep 13 and is due to complete Aug 13 [6].
29/07/2013 11:06:49
May 13: Topline results reported from the 6-month PIII AUGMENT/COPD (n=1,692). The first co-primary endpoint was a comparison of aclidinium/formoterol 400/12mcg and 400/6mcg vs aclidinium 400mcg alone in change from baseline in FEV1 at 1 hour post-dose at week 24. Both combination doses achieved statistically significant improvements vs aclidinium (108mL and 87mL, respectively, both p<0.0001). For the secondary co-primary endpoint of morning predose trough FEV1 vs formoterol 12mcg, aclidinium/formoterol 400/12mcg demonstrated a statistically significant improvement (45mL, (p<0.05), but aclidinium/formoterol 400/6mcg did not (26mL). Both combinations of aclidinium/formoterol provided statistically significant improvements vs placebo in the above two comparisons (p<0.0001). The most common AEs (≥3% and reported more frequently with aclidinium/formoterol than placebo respectively) were: cough (5.1%, 3.9% and 3.6%); nasopharyngitis (4.8%, 5.1% and 3.6%); headache (4.8%, 4.2% and 3.3%); UTI (4.5%, 2.1% and 3.0%); URTI (3.0%, 3.9% and 1.5%); back pain (3.0%, 1.5% and 2.7%); diarrhoea (2.7% 3.0% and 2.4%); nausea (1.5%, 4.5% and 1.2%); and dyspnoea (1.5%, 3.3% and 1.8%) [5]
03/05/2013 09:04:52
Apr 13: Results from the 6 month PIII ACLIFORM/COPD (ACLIdinium/FORMoterol fumarate combination for Investigative use in the treatment of moderate to severe COPD) study eva luating fixed dose combinations of aclidinium and formoterol (400/6mcg and 400/12mcg twice a day) delivered by the Genuair® inhaler reported. Both combinations demonstrated statistically significant improvements in the co-primary endpoints of change from baseline in morning predose trough FEV1 vs formoterol 12mcg and in FEV1 at 1 hour post-dose vs aclidinium 400mcg both at week 24 (p<0.01 and p≤0.0001, respectively). In addition, both combinations were also associated with statistically significant improvements vs placebo in these endpoints (both p<0.0001). The most common AEs (≥3% and reported more frequently than placebo) were nasopharyngitis (7.9% for 400/6mcg and 7.8% for 400/12mcg fixed-dose combinations and 7.2% for placebo) and back pain (3.4%, 4.7% for 400/12mcg and 4.6%, respectively) [4].
17/04/2013 16:05:49
Mar 13: NCT01462942: This PIII study, which recruited 1731 patients with stable COPD from Europe, South Korea and South Africa, and examined the efficacy and safety of two aclidinium bromide/formoterol fumarate fixed-dose combinations vs individual components and placebo, completed in Feb 13 [3].
11/03/2013 17:00:23
NCT01572792: A Phase III, long-term, randomized, double-blind, extension study of the safety and tolerability of two fixed |
