Theravance Biopharma Highlights Submission of Landmark IMPACT Data to FDA to Support Expanded Label for Trelegy Ellipta
Trelegy Ellipta is a product in which
Trelegy Ellipta is the first 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 simple-to-use delivery device, the ELLIPTA® dry powder inhaler.
In a press release dated
Trelegy Ellipta is approved for use in the US for the long-term, once-daily, maintenance treatment of COPD patients who are receiving Breo (FF/VI) and require additional bronchodilation or who are receiving Breo and Incruse (UMEC). If approved, the sNDA would broaden this indication.
Our pipeline of internally discovered product candidates includes potential best-in-class medicines to address the unmet needs of patients being treated for serious conditions primarily in the acute care setting. VIBATIV® (telavancin), our first commercial product, is a once-daily dual-mechanism antibiotic approved in the U.S.,
In addition, we have an economic interest in future payments that may be made by
For more information, please visit www.theravance.com.
THERAVANCE®, the Cross/Star logo, and VIBATIV® are registered trademarks of the
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 2017 operating loss, excluding share-based compensation. These statements are based on the current estimates and assumptions of the management of
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