GlaxoSmithKline plcGSK and partner Innoviva, Inc. INVA announced positive headline results from a phase IIIb study - Salford Lung Study - on Relvar Ellipta (100/25mcg; furoate/vilanterol) for the treatment of patients with chronic obstructive pulmonary disease (COPD).
The multi-center, open-label, randomized, controlled study was conducted to compare the effectiveness and safety profile of Relvar Ellipta with existing COPD usual care, including long-acting muscarinic antagonists, long-acting beta2-agonists, and inhaled corticosteroids administered as monotherapy, dual or triple combinations.
Results showed that patients when treated with Relvar Ellipta achieved a superior reduction in exacerbations compared to usual care in an everyday clinical practice setting. For the primary effectiveness analysis, a statistically significant reduction (8.41%) in the rate of moderate or severe exacerbations compared with those receiving usual care was found in patients treated with Relvar Ellipta. In the intent-to-treat population, the incidence of serious adverse events was found to be similar between the two groups - Relvar Ellipta (29%) and usual care (27%).
While analyses will continue, a second Salford Lung Study is currently being conducted in asthma patients with data expected in 2017.
We note that Relvar Ellipta is approved in Europe for the symptomatic treatment of adults with COPD with FEV1
The drug is marketed as Breo Ellipta in the U.S. for the long-term, once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema and to reduce exacerbations of COPD in patients with a history of exacerbations. Relvar/Breo Ellipta registered sales of £257 million in 2015.
Considering that Glaxo's respiratory franchise is under significant pressure with Advair/Seretide facing increasing competition, Glaxo is currently looking to make up for the loss of revenues in the respiratory segment with the launch of new products like Nucala, Anoro Ellipta and Relvar/Breo Ellipta and others.
Both Glaxo and Innoviva carry a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Bristol-Myers Squibb Company BMY and ANI Pharmaceuticals, Inc. ANIP , each sporting a Zacks Rank #1 (Strong Buy).
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