GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said last week that they filed a regulatory submission with the European Medicines Agency for the once-daily, triple-combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) for patients with chronic obstructive pulmonary disease. Last month, the companies submitted a new drug application for the inhaled therapy to the FDA for approval in the U.S.
The triple combination therapy is made up of 3 drugs – an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting beta-adrenergic agonist. The treatment is delivered once a day using GSK’s Ellipta dry powder inhaler. The regulatory submission is backed by clinical data that includes the phase III Fulfil study, which compared once daily FF/UMEC/VI with AstraZeneca‘s (NYSE:AZN) twice daily Symbicort Turbohaler in patients with advanced COPD. The triple combo therapy demonstrated improved lung function and statistically significant reductions in exacerbations.
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