GSK said that it has applied to obtain an additional indication for Trelegy Ellipta, an asthma inhaler, to the U.S. Food and Drug Administration. The treatment received approval from the FDA to treat chronic obstructive pulmonary disease (COPD) in September 2017.
|GSK's asthma treatment Trelegy Ellipta|
The company said that the submission of the application is supported by the pivotal phase 3 CAPTAIN study, conducted in 2,436 adult patients in 15 countries with uncontrolled asthma. GSK had reported the positive headline results in May.
Although many view asthma as an inflammatory condition, the company has proved that additional bronchodilation administered through multiple-inhalers can have a beneficial effect on asthma symptoms and lung function.
GSK said Trelegy Ellipta can become a new treatment paradigm for managing those adult patients who remain symptomatic on a long-acting beta-2 agonist (LABA) and an inhaled corticosteroid (ICS) combination
“Around 30 percent of asthma patients adherent to ICS/LABA combination therapy still experience symptoms,” said Christopher Corsico, senior vice president of development at GSK. “This filing is an important step toward giving asthma patients an additional treatment option. If approved, this filing would make Trelegy Ellipta the first and only single inhaled triple therapy available for both asthma and COPD in the U.S.”
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