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New Drugs Online Report for glycopyrronium bromide
Information
Generic Name:
glycopyrronium bromide 
Trade Name: Seebri Breezhaler  
Synonym: NVA 237, NVA237 
Entry Type: New formulation  
 
Developmental Status
UK: Launched 
EU: Launched 
US: Phase III Clinical Trials 
UK launch Plans: Available only to registered users
Actual UK launch date: November 2012 
Comments
Nov 12: Launched in the UK [17]. 
05/11/2012 09:56:46
Oct 12: Seebri® Breezhaler® (glycopyrronium bromide) 44 mcg delivered dose (equivalent to 50 mcg glycopyrronium measured dose per capsule) approved in the EU as a once-daily inhaled maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD [16] 
02/10/2012 08:31:21
Jun 12: EU positive opinion [14]. 
22/06/2012 16:03:57
Oct 11: The FDA have asked for further clinical data on the drug [11].  
26/10/2011 14:04:06
Sept 11: EU Marketing Authorisation Application filed for glycopyrrronium as a once-daily treatment for COPD. [9] 
27/09/2011 16:45:13
Jul 11: Filings planned before end 2011 [8]. 
04/07/2011 21:47:47
US filing planned for 2011 [2]. 
11/08/2009 08:51:56
PIII studies to start Jun 09 (1). 
26/05/2009 11:23:53
 
Trial or other data
Sep 12: Pooled analyses of the GLOW 1 and 2 studies demonstrated that patients on glycopyrronium 50mcg experienced rapid, sustained and clinically meaningful bronchodilation over 52 weeks. The improvement in FEV1 was seen within five minutes after the first dose on Day 1 (+90mL at 5 minutes and +144mL at 15 minutes vs placebo; p<0.001) and was sustained throughout the 52-week period (p<0.001 vs. placebo). FEV1 AUC for 0-4h, 0-12h, 0-24h and 12-24h for glycopyrronium was statistically significantly greater than placebo (p<0.05) and numerically greater than tiotropium 18mcg (an exploratory arm in GLOW2) on Day 1 and Weeks 12, 26 and 52. Glycopyrronium significantly prolonged time to first moderate/severe exacerbation vs placebo at both Week 26 (HR 0.64; p<0.001) and Week 52 (HR 0.67; p<0.001). The results were comparable in patients treated with tiotropium. Glycopyrronium improved breathlessness measured by TDI (p<0.05) and health-related quality of life measured by SGRQ (p<0.001) at Weeks 26 and 52. The results were similar to tiotropium vs placebo [15]. 
05/09/2012 08:48:13
May 12: More data released from PIII GLOW2. NVA237 provided superior 24-hour bronchodilation vs. placebo at 12 wks (mean trough FEV1 97 mL; p<0.001). At this same time point, trough FEV1 for OL tiotropium (Spiriva® HandiHaler®/18 mcg) was 83 mL vs. placebo (p<0.001). Serious adverse events were reported less frequently with NVA237 (12.6%) than with either placebo (15.4%) or OL tiotropium (15.0%) [13]. 
21/05/2012 10:42:17
Sep 11: Further data from the GLOW1 study reported at the ERS Congress. The study met its primary endpoint: NVA237 50mcg once-daily produced an improvement in lung function of 108mL in trough FEV1 after 12 weeks in patients with moderate-to-severe COPD vs placebo (p<0.001). NVA237 had a rapid onset of action, with a 93mL improvement in FEV1 vs placebo at 5 minutes post-dose following the first dose on the first day of treatment (p<0.001). It also significantly prolonged the time to first exacerbation and reduced the % of associated hospitalizations. Significant improvement in breathlessness and health-related QoL was seen at 26 weeks together with reduction in the use of rescue medication. VA237 was well-tolerated, with a similar incidence of AEs with NVA237 and placebo [10]. 
28/09/2011 08:23:57
Sept 11: The GLOW3 study investigated the effects of glycopyrronium 50mcg once-daily on exercise endurance in moderate-to-severe COPD patients. The study met its main outcome by showing a significant 21% improvement in exercise endurance vs. placebo at the end of the study (i.e. day 21), with a significant 10% increase from day one. [9] 
27/09/2011 16:45:56
Jun 11: Top line results from the pivotal PIII GLOW2 reported. In the 52-week RCT, 1,066 patients with moderate-to-severe COPD were randomized into 3 treatment arms: once-daily glycopyrronium bromide 50mcg or placebo (double-blind), or once-daily tiotropium 18mcg (open label). COPD background therapy and rescue medication was permitted. The study met its primary endpoint of superior 24-hour bronchodilation (trough FEV1) vs placebo at 12 weeks (p<0.001). Glycopyrronium produced similar improvements in lung function to tiotropium (exploratory). Secondary endpoints included improvement in breathlessness assessed using the Transition Dyspnea Index (TDI) at 26 weeks, improved quality of life as measured by the St George´s Respiratory Questionnaire (SGRQ) at 52 weeks, time to first COPD exacerbation and use of rescue medication during 52 weeks of treatment. The study met all these endpoints. Glycopyrronium was delivered via Concept1®, a single-dose dry-powder inhaler and was well-tolerated with a similar incidence of AEs in the 3 arms [7]. 
30/06/2011 21:12:18
Apr 11: The 24-week PIII GLOW1 study met its primary endpoint, demonstrating superior bronchodilation (trough FEV1) vs placebo (p<0.001) at 12 weeks. Detailed data will be released 2H/2011 [6]. 
19/04/2011 21:10:48
Jul 10: NCT01154127 is a multi-center, randomized, double-blind, placebo-controlled, two-period cross-over PIII study to assess the effect of 50μg inhaled NVA237 on exercise endurance in 80 patients with moderate to severe COPD. The study started Jun 10 and is due to complete Feb 11. The primary outcome is exercise endurance time during a sub-maximal constant-load cycle ergometry test (SMETT) three weeks after treatment [5].  
07/07/2010 08:54:25
Jan 10: Company report positive results from a PIIa dose-ranging study of PT001, its glycopyrrolate hydrofluoroalkane metered dose inhaler. PT001 was well tolerated and was comparable in bronchodilator efficacy to tiotropium in patients with mild to moderate COPD. Pearl is also studying PT001 in combination with PT005, its formoterol fumarate inhalation aerosol [3]. 
08/01/2010 08:35:29
PIII studies expected to start in June 2009. PIII studies in combination with indacaterol, a long-acting beta-2 agonist will start Q4 2009 (1) 
26/05/2009 11:30:02
 
Evidence Based Evaluations
AWMSG  http://www.wales.nhs.uk/sites3/docopen.cfm?orgid=371&id=209813 
SMC  http://www.scottishmedicines.org/files/advice/glycopyrronium_Seebri_Breezhaler_FINAL_December_2012_amended_070113_for_website.pdf 
NICE (MPC)  http://www.nice.org.uk/mpc/evidencesummariesnewmedicines/ESNM9.jsp 
MTRAC  http://www.keele.ac.uk/media/keeleuniversity/fachealth/fachealthsop/mtrac/documents/summary/Glycopyrronium%20SUM%20final%20(1).pdf 
NYDTC  http://www.nyrdtc.nhs.uk/docs/nde/NDE_119_Glycopyrronium.pdf 
EPAR  http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002430/human_med_001580.jsp&mid=WC0b01ac058001d124 
   
References  
Available only to registered users
Category
BNF Category:
Antimuscarinic bronchodilators (03.01.02)
Pharmacology: long-acting muscarinic antagonist (LAMA)  
Epidemiology: An estimated three million people are affected by COPD in the UK. About 900,000 have been diagnosed with COPD and an estimated two million people have COPD which remains undiagnosed. The rate of COPD in the population is estimated at between 2% and 4%. The diagnosed prevalence of COPD is 1.5%. The prevalence increases with age, with an estimated prevalence of 10% in men older than 75. [12]  
Indication: Chronic obstructive pulmonary disease (COPD) 
 
Method(s) of Administration
Inhalation 
 
Company Information
Name: Novartis 
US Name: Novartis 
 
NICE Information
Anticipated Commissioning route (England)
In timetable: -  
   
   
PBR Likely in tariff.
   
Implications Available only to registered users