"Closed Triple" Therapies Archives

FDA Approves New Asthma Indication for Trelegy Ellipta

"Closed Triple" Therapies, Approvals, Asthma, Chronic Obstructive Pulmonary Disease (COPD), Data, FDA, FDA/Regulatory, Inhalers, New Indications, Supplemental New Drug Application (sNDA)

The U.S. Food and Drug Administration approved a new indication for GlaxoSmithKline plc and Innoviva Inc.’s Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’) for the treatment of asthma in patients aged 18 years and older adding to the product’s current license for use in patients with chronic obstructive pulmonary disease (COPD).

GSK’s 3-in-1 inhalable drug shows promise in asthma study

"Closed Triple" Therapies, Analysts, Asthma, Clinical Trials, COPD, FDA, Generics, Inhalers, Lung Functions, R&D

GlaxoSmithKline Plc said the company’s three-in-one drug Trelegy Ellipta met the main goal of a late-stage asthma study, signaling a possible boost to the British drugmaker’s lung medicines division.

GSK Submits Regulatory Application in Japan for Once-Daily Single Inhaler Triple Therapy FF/UMEC/VI for Patients with COPD

"Closed Triple" Therapies, COPD, Inhalers, Labour and Welfare (MHLW), Lung Disease, Molecules

GlaxoSmithKline plc and Innoviva Inc. announced the submission of a regulatory application to the Japanese Ministry of Health, Labour and Welfare for once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 100/62.5/25 mcg) under the proposed brand name of Trelegy Ellipta for the treatment of adults with chronic obstructive pulmonary disease. This is the first regulatory filing to be made in Japan for a triple COPD therapy in a single inhaler.