The European Commission has granted marketing authorization for fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) (Trelegy Ellipta, GlaxoSmithKline PLC and Innoviva, Inc) for the treatment of chronic obstructive pulmonary disease (COPD), according to a GlaxoSmithKline news release.
FF/UMEC/VI is a once-daily single inhaler triple therapy that is indicated for maintenance treatment of adults with moderate to severe COPD that is not adequately controlled by a combination of an inhaled corticosteroid and a long-acting beta2-agonist. The licensed strength is 92 μg of fluticasone furoate, an inhaled corticosteroid (ICS); 55 μg of umeclidinium, a long-acting muscarinic antagonist (LAMA); and 22 μg of vilanterol, a long-acting beta2-agonist (LABA).
The US Food and Drug Administration approved FF/UMEC/VI for the treatment of COPD on September 19, 2017.
“COPD is a serious lung disease that affects millions of people. Its progressive nature means symptoms can worsen over time, with many patients also experiencing frequent debilitating exacerbations. A combination of different types of medicines can be required to achieve treatment goals. Trelegy Ellipta is the first medicine to be approved in Europe that delivers three effective molecules in a once-daily single inhalation. We believe this is an important innovation in COPD management and look forward to making it available for appropriate patients with COPD,” Eric Dube, senior vice president and head, GSK Global Respiratory Franchise, explained in the news release.
“Knowing that appropriate COPD patients will require triple therapy, Trelegy Ellipta affords the convenience of administration of three classes of medicines in a single inhaler. Having all three major classes of combination medication (ICS/LABA, LAMA/LABA, and now single inhaler triple therapy) in the single Ellipta inhaler is an important advance in inhaled therapeutics,” Mike Aguiar, CEO of Innoviva, Inc, said in the news release.
The first European launch is anticipated in late 2017.
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