Triple Combo Therapy Breztri Aerosphere Approved in Japan for COPD

AstraZeneca’s triple combination therapy Breztri Aerosphere, formerly known as PT010, has been approved in Japan for the treatment of symptoms of chronic obstructive pulmonary disease (COPD). This makes Japan the first country to grant regulatory approval for Breztri Aerosphere. Breztri Aerosphere, which is composed of budesonide, glycopyrronium…

European Union Approves Chiesi’s COPD Maintenance Therapy Trimbow

The European Union has approved Trimbow as a maintenance treatment for adults with moderate to severe chronic obstructive pulmonary disease. Trimbow, developed by Italy’s Chiesi Group, is the first triple-combination inhaler for COPD. It contains the inhaled corticosteroid beclometasone dipropionate, the β2 agonist formoterol fumarate, and the muscarinic antagonist glycopyrronium.

GSK Submits FDA New Drug Application for COPD Triple Combination Therapy

GlaxoSmithKline (GSK), together with Innoviva, recently announced GSK submitted a New Drug Application (NDA) with the U.S. FDA for the triple combination therapy FF/UMEC/VI (fluticasone furoate/umeclidinium/vilanterol) to treat chronic obstructive pulmonary disease (COPD). GSK announced earlier this year that it was planning to advance the timing of the filing with…

Triple Combination Therapy Shows Promise in COPD; Superior to Symbicort/Turbohaler Therapies

GlaxoSmithKline and Innoviva announced positive data from the Phase 3 FULFIL clinical trial evaluating their investigational triple combination therapy with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/IV) in patients with chronic obstructive pulmonary disease (COPD). FULFIL is a randomized, double-blind, multicenter study designed to evaluate the efficacy and safety of a daily dose of the FF/UMEC/IV…