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Theravance Biopharma, Inc. (NASDAQ: TBPH) today emphasized that the European Commission approved the extended label of Trelegi Ellipta (fluticasone furoate / umeclidinium / vilanterol & apos; FF / UMEC / VI & apos;), which recognized the effect of the product on deterioration and the formation of the first three inhaled triple therapy for patients with moderate to severe chronic obstructive pulmonary disease (COPD) not adequately treated with double bronchodilation or with inhaled corticosteroid (ICS) and long-acting β2 agonist (LABA).
Trelegi Ellipta is a product in which Theravance Biopharma has an economic interest in future payments that can be made by GlakoSmithKline (GSK) or one of its subsidiaries in accordance with its Innovivi contracts (formerly Theravance, Inc.). Theravance Biopharma is entitled to receive 85% of the economic interest for a license paid by GSK on world net sales. These royalties are in the range of 6.5% to 10%, leading to cash flow in Theravance Biopharma from about 5.5% to 8.5% of the worldwide net sales of Trelegi Ellipta.
Trelegi Ellipta is the first treatment of HOBP that provides a combination of three molecules in one inhaler that is needed only once a day. Unique combined treatment includes: FF, ICS; UMEC, long-acting muscular antagonist (LAMA); and VI, LABA. This combination is formulated to be delivered once a day in the GSK ELLIPTA® dry powder inhaler.
U a Press release On November 9, 2018, GSK and Innoviva announced that the European Commission approved an expanded label for Trelegi Ellipt in Europe. According to the company's data, the extended indication reflects evidence that supports its potential benefits in a broader group of patients than initially indicated, giving them the ability to take a one-day, single-dose inhalation triple therapy for the first time. The update of the label is based on data from the InforMing-oriented PASTA HOBP (IMPACT) study that showed that Trelegi Ellipta was superior to both ICS / LABA Relvar / Breo Ellipta (FF / VI) and LAMA / LABA Anoro Ellipta (UMEC / VI) in patients with moderate to severe COPD at several clinically important endpoints, including decreased deterioration and improved lung function and quality of life related to health.
A new indication for Trelegi Ellipta is a maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated with the combination of ICS and LABA or a combination of LABA and LAMA (for effects on symptom control and prevention of exacerbations, see section 5.1). It was originally approved in the European Union (EU) in November 2017 as maintenance treatment in adult patients with moderate to severe COPD who were not adequately treated with the combination of ICS and LABA (for effects on symptom control, see section 5.1).
European Product Characteristics Summary is available at: https: //v.medicines.org.uk/emc/medicine/34357.