![]() ![]() Some COPD patients with severe symptoms were already using all 3 therapies with multiple inhalers, but this new therapy offered the chance to combine all 3 molecules in a single inhaler, used once a day. The triple therapy from GlaxoSmithKline combines the inhaled glucocorticoid fluticasone furoate (FF) with umeclidinium (UMEC), a long-acting muscarinic antagonist (LAMA), and the LABA vilanterol (VI). The session also covered upcoming label changes for cough syrup to keep medicines with opioids away from children, a new treatment for cystic fibrosis, and more choices for treating severe asthma. FDA’s Banu Kamiri-Shah, MD, discussed how the fixed-dose combination therapy rule works for COPD medications, and how the rule was interpreted in the approval process for triple therapy. Officials from the FDA Division of Pulmonary, Allergy, and Rheumatology Products (DPARP) explained how the agency’s processes led to 2 landmark decisions in the past year involving combination therapy in asthma and COPD, during Monday’s update for attendees at the annual ATS meeting, taking place in San Diego, California.īesides the September approval for Trelegy Ellipta, in December FDA removed the boxed warning from several therapies that combine an inhaled corticosteroid (ICS) and a long-acting beta2-adrenergic agonist (LABA). What’s more, in designing a large trial for a specific population-patients with a history of exacerbations-GlaxoSmithKline found that its drug produced a dramatic reduction in all-cause mortality, compared with the treatment many patients would be taking before they tried triple therapy. This allowed Trelegy Ellipta to go from a narrow indication in September 2017 to a broader approval on April 24, 2018, based on results from IMPACT. Lipson presented full results from IMPACT on Sunday, at the American Thoracic Society (ATS) 2018 International Conference, and on Monday an FDA official described how the trial’s design addressed specific requirements in the agency’s rule for fixed-dose combinations. Globally, there’s been a question about the benefit-risk balance of using inhaled corticosteroids in COPD,” he said. But they also increase risk of pneumonia. “We know that inhaled steroids reduce risk of exacerbation. “There has been a long controversy in the use of inhaled corticosteroids in COPD,” said David Lipson, director of clinical drug discovery for GlaxoSmithKline, in an interview with The American Journal of Managed Care®. When GlaxoSmithKline designed the IMPACT trial for Trelegy Ellipta, it sought to fill gaps in the evidence: would adding an inhaled corticosteroid (ICS) benefit patients with chronic obstructive pulmonary disease (COPD) who were having exacerbations? ![]()
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