Skip to main content

Theravance Biopharma declare Filing of EU Regulatory Submission by GSK and Innoviva

 

Clinical courses

Theravance Biopharma, Inc. announced that GlaxoSmithKline plc (GSK) and Innoviva, Inc. (Innoviva) have filed a Marketing Authorization Application (MAA) in the European Union for the Closed Triple (the combination of fluticasone furoate, umeclidinium, and vilanterol in a single ELLIPTA® inhaler) for patients with chronic obstructive pulmonary disease (COPD). 

The Closed Triple is one of the drug development programs for which Theravance Biopharma has an economic interest in future payments that may be made by GSK or one of its affiliates pursuant to its agreements with Innoviva (formerly Theravance, Inc.).  Should the Closed Triple be approved and commercialized, Theravance Biopharma is entitled to receive an 85% economic interest in the royalties paid by GSK on worldwide net sales. 

Those royalties are upward-tiering from 6.5% to 10%.  Additionally, Theravance Biopharma is not responsible for any costs related to the Closed Triple.

In an announcement made on December 2, 2016, GSK and Innoviva stated GSK has filed a regulatory submission with the European Medicines Agency for the once-daily, Closed Triple combination therapy.  This follows the companies' announcement of the filing of a New Drug Application for the Closed Triple in the United States in November 2016.  The EU regulatory submission of the Closed Triple comprises an MAA for a maintenance treatment to relieve symptoms of adult patients with COPD.  It is based on data from the Closed Triple combination therapy development program, as well as data from studies with fluticasone furoate, umeclidinium, and vilanterol either alone or in combination.  The announcement from GSK and Innoviva also noted that regulatory submissions of the Closed Triple therapy for COPD are anticipated in the rest of the world beginning in 2017.

 

The Closed Triple combination therapy represents a unique approach to COPD treatment by seeking to combine the activity of three molecules with different mechanisms of action in a single, simple-to-use delivery device. 

The combination treatment includes: fluticasone furoate (FF), an inhaled corticosteroid; umeclidinium (UMEC), a long-acting muscarinic antagonist (LAMA); and vilanterol (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.

Current trends in the treatment of COPD with combination therapy support Theravance Biopharma's view that there is significant market potential for a first-in-class, once-daily Closed Triple.  According to GSK, approximately one-third of COPD patients are already utilizing open triple therapy and the progressive nature of the disease indicates that COPD patients will need access to more effective therapies over time.  Additionally, recently reported results from the Salford Lung Study, a Phase 3 real-world effectiveness trial of two of the components of Closed Triple (FF and VI) in COPD exacerbations, were strongly supportive of the benefits of once-daily therapy.

The ongoing clinical development program for the Closed Triple in COPD includes the IMPACT study, a large Phase 3 trial designed to evaluate the efficacy and safety of the triple combination treatment compared to dual COPD therapies (FF/VI and UMEC/VI).  Results of the IMPACT study are expected to be reported by GSK in 2017.

The Closed Triple is also in development for the treatment of symptomatic asthma.  A regulatory submission in this indication is planned for 2018 according to GSK.  The Closed Triple is not approved for use anywhere in the world.

<< Pharma News

Subscribe to PharmaTutor News Alerts by Email