Theravance Biopharma Highlights Positive CHMP Opinion Supporting Expanded COPD Indication for Trelegy Ellipta in Europe
The expanded indication for the once-daily single inhaler triple therapy would enable use by patients not adequately treated by a long-acting muscarinic antagonist (LAMA) and long-acting beta2-agonist (LABA). It would also reference the effect on exacerbations based on data from the InforMing the PAthway of COPD Treatment (IMPACT) study.
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 (ICS); UMEC, a LAMA; and VI, a LABA. This combination has been formulated to be delivered once-daily in GSK's ELLIPTA® dry powder inhaler.
In a press release dated
Trelegy Ellipta was originally approved in the
A CHMP positive opinion is one of the final steps before a final decision on the regulatory update is granted by 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.
In addition, we have an economic interest in future payments that may be made by
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This press release contains certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations and future events. Theravance Biopharma intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to: the Company's strategies, plans and objectives, the Company's regulatory strategies and timing of clinical studies (including the data therefrom), the potential benefits and mechanisms of action of the Company's product and product candidates, the Company's expectations for product candidates through development, potential regulatory approval and commercialization (including their potential as components of combination therapies), product sales and the Company's expectations for its 2018 operating loss, excluding share-based compensation. These statements are based on the current estimates and assumptions of the management of
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