GSK files EU regulatory submission for once-daily closed triple combination therapy FF/UMEC/VI for patients with COPD

Issued: London UK – LSE Announcement 

GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced the filing by GSK of a regulatory submission with the European Medicines Agency for once-daily, closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 100/62.5/25 mcg) for patients with chronic obstructive pulmonary disease (COPD). This follows the announcement of the submission of a New Drug Application for FF/UMEC/VI in the US in November 2016.

The closed triple combination therapy comprises three medicines: fluticasone furoate, an inhaled corticosteroid (ICS), umeclidinium, a long-acting muscarinic antagonist (LAMA) and vilanterol, a long-acting beta2-adrenergic agonist (LABA), delivered once-daily in GSK’s Ellipta® dry powder inhaler.

The EU regulatory submission of closed triple therapy comprises a Marketing Authorisation Application for a maintenance treatment to relieve symptoms of adult patients with COPD. It is based on data from the closed triple combination therapy development programme including data from the phase III FULFIL study, as well as data from studies with FF, UMEC and VI either alone or in combination.

Dave Allen, Head, Respiratory Therapy Area Unit, R&D, said, “Many patients with COPD are already at an advanced stage when they are diagnosed. Prescribing patterns show the importance of having a range of options available to meet the differing needs of individual patients. An approval of our closed triple therapy in Europe would complement our portfolio of inhaled therapies designed for once-daily dosing in a single inhaler, offering patients a convenient, alternative option.”

Mike Aguiar, CEO of Innoviva, Inc., added “The EU filing of the closed triple combination is the latest development in our long-standing collaboration with GSK. If approved, FF/UMEC/VI as once daily triple combination in a single inhaler could be a meaningful addition to the treatment options available for advanced COPD patients.”

Regulatory submissions of closed triple therapy for COPD are anticipated in the rest of the world beginning in 2017. The closed triple combination of FF/UMEC/VI is not approved for use anywhere in the world.

About COPD

COPD is a disease of the lungs that includes chronic bronchitis, emphysema or both. COPD is characterised by obstruction to airflow that interferes with normal breathing.COPD is thought to affect 329 million people worldwide.

Long-term exposure to lung irritants that damage the lungs and the airways are usually the cause of COPD. Cigarette smoke, breathing in second hand smoke, air pollution, chemical fumes or dust from the environment or workplace can all contribute to COPD. Most people who have COPD are at least 40 years old when symptoms begin.

Innoviva – Innoviva is focused on bringing compelling new medicines to patients in areas of unmet need by leveraging its significant expertise in the development, commercialization and financial management of bio-pharmaceuticals. Innoviva's portfolio is anchored by the respiratory assets partnered with Glaxo Group Limited (GSK), including RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®, which were jointly developed by Innoviva and GSK. Under the agreement with GSK, Innoviva is eligible to receive associated royalty revenues from RELVAR®/BREO® ELLIPTA®, ANORO® ELLIPTA® and, if approved and commercialized, VI monotherapy, as well. In addition, Innoviva retains a 15 percent economic interest in future payments made by GSK for earlier-stage programs partnered with Theravance Biopharma, Inc., including the closed triple combination therapy for COPD. For more information, please visit Innoviva's website at www.inva.com.

GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com.

RELVAR®, BREO®, ANORO® and ELLIPTA® are trademarks of the GlaxoSmithKline group of companies.