GlaxoSmithKline and Innoviva: The COPD inhaler Relvar® Ellipta® (known as Brio Ellipta in the United States) Demonsterates Superiority Over Usual Care.
According to GlaxoSmithKline plc (GSK) and Innoviva (INVA), the results came fromSalford lung study, which demonstrated that Relvar® Ellipta® 100/25mcg (fluticasone furoate ‘FF’/vilanterol ‘VI’ or ‘FF/VI’) achieved a superior reduction in exacerbations versususual care in patients with chronic obstructive pulmonary disease COPD, in an everyday clinical practice setting.
The Usual care included long-acting muscarinic antagonists (LAMA), long-acting beta2-agonists (LABA), and inhaled corticosteroids (ICS) administered as monotherapy, dual or triple combinations.
For the primary effectiveness analysis: Patients treated with Relvar® Ellipta®100/25mcg had a statistically significant reduction of 8.41% in the rate of moderate or severe exacerbations compared with those receiving usual care (p=0.025).
Within the intent-to-treat (ITT) population: The incidence of serious adverse events (SAE) was similar between the groups (29% FF/VI, 27% usual care). For pneumonia, an SAE of special interest, FF/VI demonstrated non-inferiority versus usual care (7% FF/VI versus 6% usual care).
This endpoint was a regulatory post-authorization measure requested by the European Medicines Agency (EMA).
Explaining the meening of the study, lead investigator, Jørgen Vestbo, Professor of Respiratory Medicine at the Centre for Respiratory Medicine and Allergy, University Hospital South Manchester NHS Foundation Trust and the University of Manchester, said:
“The Salford Lung Study is a very important trial to help us understand more about the medicines we prescribe on a day-to-day basis. This is an important finding; what we are seeing today is the tip of the iceberg. Over the coming months we will understand more about the day-to-day effectiveness of FF/VI and how treatment choice, patient behavior, co-morbidities and other factors combine to influence COPD outcomes. This has been a highly collaborative effort to gather data that will help improve understanding about the effectiveness of respiratory medicines when used in usual clinical practice.”
Michael W. Aguiar, President and Chief Executive Officer of Innoviva said:
“We are very pleased that Relvar Ellipta achieved superiority compared to usual care in SLS, a world-first effectiveness study in COPD. These data provide a significant body of evidence in everyday clinical practice and add to the data generated from other randomized controlled studies. These data are unique in the world of evidence generation in COPD. We look forward to disclosing further data and analyses, which we believe will be of significant value to both physicians and patients.”
The Salford Lung Study is intended to enable healthcare professionals and decision makers to more fully assess the potential value of Relvar® Ellipta® by providing data collected in a normal clinical practice setting which is representative of how healthcare professionals and patients may use the medicine in everyday life. The study will add to the existing data set from randomized clinical trials (RCTs) for the medicine which, while critical to establishing the safety and efficacy of a medicine, are conducted in a highly controlled environment and enroll a more highly selected patient population than would be expected in everyday clinical care.
The study is made possible through a unique collaboration between GSK, North West e-Health (NWEH), The University of Manchester, Salford Royal NHS Foundation Trust, University Hospital of South Manchester (UHSM), NHS Salford and GPs and community pharmacists in Salford, Trafford and South Manchester.
To read more about the study and the product’s safety, click HERE or copy this link : http://investor.inva.com/releasedetail.cfm?ReleaseID=972501
The study is listed on www.clinicaltrials.gov.
The news is good for both GSK and INVA and more importantly for COPD patients. Breo® Ellipta® (FF/VI 100/25mcg) is taken only once a day, which is advantageous over the twice a day currently available long acting COPD inhalers.
In the US., Breo® Ellipta® 100/25mcg is approved for long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema and to reduce exacerbations of COPD in patients with a history of exacerbations.
Regarding Innoviva, the news came at the perfect time when the drug sales are beginning to rise and now expected to continue rising slowly, but surely towards reaching its maximum for both the COPD indication and the Astma indication. Important to know that a second Salford Lung Study is currently being conducted in asthma patients and the results are expected in 2017.
Innoviva royalties: GSK pays Innoviva royalties on net sales of RELVAR®/BREO® ELLIPTA® of 15% for the first $3.0 billion of annual global net sales. It will pay 5% for all annual global net sales above $3.0 billion.
In addition, Innoviva retains a 15% economic interest in future payments made by GSK for earlier-stage programs.
This news is also good regarding Innoviva’s scientific innovation and scientists’ capabilities. We should not forget Theravace Biotherapeutics (TBPH), which is responsible for developing the pipeline products inherited from Innoviva.
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