Chalk up another real-world trial win for GlaxoSmithKline. A year after showing the company’s Breo Ellipta could beat out go-to COPD treatments at cutting down exacerbations, new data says the medication trumps usual care at controlling asthma, too.
The pharma giant rolled out results Friday showing that the respiratory med—known as Relvar in Europe—had hit its primary endpoint in the so-called Salford Lung Study, coming out twice as likely to spur an improvement in asthma control than commonly used inhaled corticosteroids (ICS) or ICS/LABA combos.
Salford wasn’t a typical trial for the drugmaker—nor for the wider pharmaceutical industry. The 4,233-patient study followed participants for one year in a normal clinical practice setting, mining electronic medical records and linking primary care, secondary care and pharmacy data to collect results. Physicians could modify or switch treatments at any time, just as they would in their normal practice.
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The result was a trial that “measured the effectiveness and safety of a medicine while closely reflecting how typical asthma patients are managed in everyday clinical practice, providing meaningful data for the healthcare community,” a company spokesperson said via email.
“GSK should be congratulated for running this unique study,” lead Salford investigator Ashley Woodcock added in a statement.
Glaxo, however, isn’t looking for kudos as much as a bump in its respiratory market share. While Breo has picked up recently after a slow start, it’s still got big shoes to fill as competitors gear up to finally launch their generic knockoffs of megablockbuster Advair.
So far at least, GSK has lucked out with a delay to rival Mylan, but it knows it can’t count on the setback to keep copycats out of the picture all year. After the first quarter, it kept its guidance—which included midyear generic entry—intact.