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| Date: 11 Jan 2012 |
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Definition of medical terminology for Medicine.
GlaxoSmithKline and Theravance, Inc. announced the completion of the phase III registration programme for the once-daily investigational medicine Relovair
Definition of medical terminology for Patients.
Definition of medical terminology for Disease.
Definition of medical terminology for Patients.
One of the genes that predisposes a person to asthma.
A common disorder in which chronic inflammation of the bronchial tubes (bronchi) makes them swell, narrowing the airways.
Definition of medical terminology for Medicine.
Definition of medical terminology for Patients.
chronic obstructive pulmonary disease
One of the genes that predisposes a person to asthma.
Definition of medical terminology for Programs.
Definition of medical terminology for Future.
chronic obstructive pulmonary disease
Definition of medical terminology for Patients.
Definition of medical terminology for Dose 50, Lethal.
FDA Information Retrieval System
Definition of medical terminology for Review.
Definition of medical terminology for Dose 50, Lethal.
Definition of medical terminology for Lung.
An appendage in anatomy and in clinical trials.
Definition of medical terminology for Respiratory Tract.
Definition of medical terminology for Sinusitis.
Definition of medical terminology for Pneumonia.
Definition of medical terminology for Dose 50, Lethal.
Definition of medical terminology for Safety.
A psychology term for processes used to gain understanding of complex emotional or behavioral issues.
Definition of medical terminology for Lung.
Definition of medical terminology for Patients.
Definition of medical terminology for Placebo Effect.
Definition of medical terminology for Filing.
chronic obstructive pulmonary disease
Blood Availability and Safety Inventory System (HHS)
A common disorder in which chronic inflammation of the bronchial tubes (bronchi) makes them swell, narrowing the airways.
Definition of medical terminology for Patients.
FDA Information Retrieval System
Definition of medical terminology for Lung.
Definition of medical terminology for Respiratory Tract.
Definition of medical terminology for Pain.
Definition of medical terminology for Influenza.
An appendage in anatomy and in clinical trials.
Definition of medical terminology for Safety.
A psychology term for processes used to gain understanding of complex emotional or behavioral issues.
Definition of medical terminology for Lung.
Definition of medical terminology for Lung.
Definition of medical terminology for Patients.
Definition of medical terminology for Placebo Effect.
Definition of medical terminology for Study Characteristic, Epidemiologic.
Definition of medical terminology for Patients.
FDA Information Retrieval System
The axis is the second cervical vertebra (symbol: C2).
Definition of medical terminology for Safety.
Definition of medical terminology for Safety.
A common disorder in which chronic inflammation of the bronchial tubes (bronchi) makes them swell, narrowing the airways.
Definition of medical terminology for Filings.
Definition of medical terminology for Patients.
chronic obstructive pulmonary disease
One of the genes that predisposes a person to asthma.
chronic obstructive pulmonary disease
A common disorder in which chronic inflammation of the bronchial tubes (bronchi) makes them swell, narrowing the airways.
chronic obstructive pulmonary disease
A common disorder in which chronic inflammation of the bronchial tubes (bronchi) makes them swell, narrowing the airways.
Definition of medical terminology for Patients.
Definition of medical terminology for Survival.
chronic obstructive pulmonary disease
Definition of medical terminology for Patients.
Definition of medical terminology for Disease.
Definition of medical terminology for Risk.
Definition of medical terminology for Disease.
Definition of medical terminology for Standards.
A common disorder in which chronic inflammation of the bronchial tubes (bronchi) makes them swell, narrowing the airways.
chronic obstructive pulmonary disease
Definition of medical terminology for Kinase.
A bronchodilator medicine that opens the airways by relaxing the muscles around the airways that may tighten during an asthma attack or in COPD (chronic obstructive pulmonary disease).
chronic obstructive pulmonary disease
One of the genes that predisposes a person to asthma.
Definition of medical terminology for Medicine.
An agency of the United Nations established in 1948 to further international cooperation in improving health conditions.
Definition of medical terminology for Name.
An agency of the United Nations established in 1948 to further international cooperation in improving health conditions.
Definition of medical terminology for Healthcare.
Definition of medical terminology for Life.
Definition of medical terminology for Medicines.
Of or pertaining to bacteria.
Definition of medical terminology for Nervous System.
Definition of medical terminology for Programs.
Definition of medical terminology for Opioid Receptor.
In biochemistry, an antagonist acts against and blocks an action.
Definition of medical terminology for Program Acceptability.
Definition of medical terminology for Medicines.
Definition of medical terminology for Need Certificate.
Definition of medical terminology for Medicines.
(fluticasone furoate aFFa/vilanterol aVIa) in patients with chronic obstructive pulmonary disease (COPD) and of all but one of the pivotal studies in patients with asthma .
For COPD, GSK intends to submit regulatory applications in the US and Europe in mid-2012. For asthma, GSK plans to submit an application in Europe in mid-2012 and will continue discussions with the FDA on the regulatory requirements for a US asthma indication.
Darrell Baker, SVP Respiratory Portfolio Optimisation Leader at GSK said: aWe are pleased to have reached this milestone for RelovairTM, one of the important assets in our respiratory development portfolio. Having undertaken an initial assessment of these data we believe they support our plan to seek global approvals of this once-daily medicine for the treatment of patients with COPD and asthma .a
Rick E Winningham, Chief Executive Officer of Theravance said: aWe are very excited with the new data and GSKas plan to submit regulatory applications for Relovaira in the US and Europe this year. Relovaira is one of our three respiratory programs with GSK.a
The full results of these pivotal studies will be presented at future scientific meetings.
COPD Programme
The COPD programme included two replicate 52-week exacerbation studies each of which randomised approximately 1,620 patients. The studies were powered to compare each of 3 doses of FF/VI (200/25mcg, 100/25mcg and 50/25mcg) to VI 25mcg alone in a step-wise manner, starting at the highest dose . In both studies, all doses of FF/VI demonstrated reductions in the annual rate of moderate to severe exacerbations compared with VI alone. In the first study, the reductions were statistically significant at all doses (200/25mcg p<0.001, 100/25mcg p=0.024, 50/25mcg p=0.040). In the second study, the reductions were not statistically significant at the highest dose (200/25mcg). The p-values in this study were p=0.109 (200/25mcg), p<0.001 (100/25mcg) and p=0.181 (50/25mcg). GSK and Theravance believe that it is appropriate to request that regulatory authorities review the totality of the exacerbation data, including the effects seen across both studies for the 100/25mcg dose .
In both exacerbation studies, all doses of FF/VI demonstrated numerical increases in lung function compared with VI, but not all increases were significant.
Across these two studies, the most common adverse events in the FF/VI arms included nasopharyngitis, upper respiratory tract infection, oral candidiasis, headache, COPD, back pain, pneumonia, bronchitis and sinusitis. GSK is investigating reports of fatal pneumonia on FF/VI primarily at the 200/25mcg dose . An integrated safety and tolerability analysis is underway.
A 4-week detailed lung function profile study in 54 patients demonstrated that all doses of FF/VI (50/25mcg, 100/25mcg, and 200/25mcg) statistically significantly increased weighted mean FEV1 versus placebo .
In a non-pivotal 12-week superiority study of FF/VI 100/25mcg once daily compared with SeretideA (fluticasone propionate/salmeterol (FP/SAL)) 500/50mcg twice daily, FF/VI did not meet the predefined threshold for superiority on 0-24 hour weighted mean FEV1(p=0.282). There was no statistical difference between FF/VI and FP/SAL.
GSK anticipates filing the FF/VI 100/25mcg dose for COPD on a global basis starting in mid-2012.
Asthma Programme
GSK has also completed asthma studies, which form the majority of the phase III registration programme for FF/VI.
An exacerbation study, which randomised approximately 2,000 patients for up to 76 weeks, demonstrated that FF/VI 100/25mcg significantly increased time to first severe exacerbation (p=0.036) and significantly decreased annual rate of severe exacerbations (p=0.014) compared to FF. The study also found that FF/VI improved trough FEV1 at all pre-defined time points over the 76-week treatment period (p<0.001 vs. FF), demonstrating a contribution by VI to the improvement in lung function of FF/VI.
In this study, the most frequent adverse events were headache, nasopharyngitis, upper respiratory tract infection, bronchitis, cough, oropharyngeal pain and influenza. There were no differences in the number of asthma-related hospitalisations between the treatment arms. There were no asthma-related deaths. An integrated safety and tolerability analysis is underway.
A 24-week study in approximately 600 moderate to severe asthmatics demonstrated superiority of FF/VI 200/25mcg over FF 200mcg on both trough FEV1 (p<0.001) and weighted mean FEV1 (p=0.048), demonstrating a contribution by VI to the improvement in lung function of FF/VI. FF 200mcg dosed once daily was non-inferior to fluticasone propionate (FP) 500mcg dosed twice daily on trough FEV1.
A 12-week placebo-controlled study evaluating lung function in approximately 600 mild to moderate asthmatics given FF/VI 100/25mcg, did not demonstrate statistically significant improvements compared to FF 100mcg on either trough FEV1 (p=0.405) or weighted mean FEV1 (p=0.06). Both FF/VI and FF demonstrated statistically significant improvements against placebo on the same endpoints (p<0.001).
In a 12-week study conducted in approximately 340 patients receiving inhaled corticosteroids throughout the study, once-daily VI 25mcg and twice-daily salmeterol (SAL) 50mcg showed no statistically significant difference on 24-hour weighted mean FEV1 compared to placebo . The lack of numerical improvement of SAL (the active control) over placebo in this study was unexpected and confounded interpretation of the study .
A 24-week study in approximately 330 patients comparing the efficacy of FF and FP to placebo is currently ongoing and will be completed during the first half of 2012.
In a non-pivotal 24-week superiority study of FF/VI 100/25mcg once daily compared with SeretideA (fluticasone propionate/salmeterol (FP/SAL)) 250/50mcg twice daily, FF/VI did not meet the predefined threshold for superiority on 0-24 hour weighted mean FEV1 (p=0.162). There was no statistical difference between FF/VI and FP/SAL.
A 6-week HPA axis study and a 52-week safety study to evaluate the safety profile of FF/VI in asthma have also been completed. The results from both studies support the planned regulatory filings.
These recently completed Phase III studies evaluated approximately 9,000 patients with COPD and asthma . The totality of the data provides GSK with the confidence to proceed with global registration for Relovair in COPD and asthma beginning in mid-2012.
Ongoing Development Programme
The development programmes for FF/Vl in COPD and asthma will continue as planned and include an outcomes study of 16,000 patients to prospectively evaluate the effect of the combination (FF/VI 100/25mcg) compared with placebo on survival in COPD patients with moderate disease and a history of, or at risk from, cardiovascular disease. In addition, GSK is in the process of setting up pre-registration real-world effectiveness studies to investigate the potential effects of FF/VI versus the standards of care in asthma and COPD. These studies are expected to commence shortly.
FF/VI is one of several late-stage assets in the GSK respiratory development portfolio, which includes LAMA/LABA (GSK573719/VI) and MABA (GSK961081), developed in collaboration with Theravance, as well as FLAP-inhibitor (GSK2190915), p-38 kinase inhibitor (losmapimod) and anti-IL5 MAb (mepolizumab). The phase III programme for LAMA/LABA is expected to complete in 2012.
*Relovaira is a once-daily inhaled corticosteroid (ICS)/long-acting beta-agonist (LABA) combination treatment, comprising fluticasone furoate and vilanterol (FF/VI), currently in development for the treatment of COPD and asthma . This investigational medicine is not currently approved anywhere in the world .
Relovaira is a trademark of the GlaxoSmithKline group of companies. The use of the brand name Relovaira for FF/Vl is not approved by regulatory authorities around the world . SeretideA and AdvairA are registered trademarks of GSK.
GlaxoSmithKline a one of the worldas leading research-based pharmaceutical and healthcare companies a is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
Theravance a is a biopharmaceutical company with a pipeline of internally discovered product candidates and strategic collaborations with pharmaceutical companies. Theravance is focused on the discovery, development and commercialization of small molecule medicines across a number of therapeutic areas including respiratory disease, bacterial infections, and central nervous system (CNS)/pain. Theravanceas key programs include: Relovaira, LAMA/LABA (a719/VI) and MABA (Bifunctional Muscarinic Antagonist-Beta2 Agonist), each partnered with GlaxoSmithKline plc, and its oral Peripheral Mu Opioid Receptor Antagonist (PIMA) program . By leveraging its proprietary insight of multivalency to drug discovery, Theravance is pursuing a best-in-class strategy designed to discover superior medicines in areas of significant unmet medical need .
THERAVANCEA, the Theravance logo, and MEDICINES THAT MAKE A DIFFERENCEA are registered trademarks of Theravance, Inc.
Source :
DrugsFreeList.com
Tags:
Theravance, Relovair, asthma, fluticasone, bronchitis
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