Theravance Biopharma Highlights Approval of Expanded Indication in the US for Once-Daily Trelegy Ellipta for Treatment of COPD Patients
Trelegy Ellipta is a product in which
Trelegy Ellipta is the first COPD treatment to provide a combination of three molecules in a single inhaler that only needs to be taken once a day. The unique combination treatment includes: FF, an inhaled corticosteroid; UMEC, a long-acting muscarinic antagonist (LAMA); and VI, a long-acting beta2-adrenergic agonist (LABA). This combination has been formulated to be delivered once-daily in GSK's ELLIPTA® dry powder inhaler.
In a press release dated
The approval is based on a supplemental New Drug Application (sNDA) supported by data from the landmark InforMing the PAthway of COPD Treatment (IMPACT) study which showed Trelegy Ellipta was superior to the inhaled corticosteroid/long-acting beta2-adrenergic agonist (ICS/LABA), Relvar/Breo Ellipta (FF/VI), and long-acting muscarinic antagonist/long-acting beta2-adrenergic agonist (LAMA/LABA), Anoro Ellipta (UMEC/VI), on multiple clinically important endpoints, including reducing exacerbations and improving lung function and health related quality of life.
Trelegy Ellipta was originally approved for use in the US in
The boxed warning has also been removed from the Trelegy Ellipta prescribing information, in line with the recent updates to the ICS/LABA class. Labelling changes to ICS/LABA combination medicines were implemented following a review of safety data submitted to the
In our relentless pursuit of this objective, we strive to apply insight and innovation at each stage of our business, including research, development and commercialization, and utilize both internal capabilities and those of partners around the world. Our research efforts are focused in the areas of inflammation and immunology. Our research goal is to design localized medicines that target diseased tissues, without systemic exposure, in order to maximize patient benefit and minimize risk. These efforts leverage years of experience in developing localized medicines for the lungs to treat respiratory disease. The first potential medicine to emerge from our research focus on immunology and localized treatments is an oral, intestinally restricted pan-Janus kinase (JAK) inhibitor, currently in development to treat a range of inflammatory intestinal diseases. Our pipeline of internally discovered product candidates will continue to evolve with the goal of creating transformational medicines to address the significant needs of patients.
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