LONDON, UK I September 15, 2017 I GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for fluticasone furoate/ umeclidinium/vilanterol (FF/UMEC/VI) as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist (for effects on symptom control see section 5.1). The proposed brand name is Trelegy Ellipta.
Trelegy Ellipta is a combination of an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA) and a long-acting beta2-adrenergic agonist (LABA), delivered once daily in GSK’s Ellipta dry powder inhaler. It is the first once-daily single inhaler triple therapy to be granted a positive opinion by the CHMP. The proposed strength is FF/UMEC/VI 100/62.5/25 mcg.
Patrick Vallance, GSK’s President, R&D, said, “We believe once-daily single inhaler triple therapy, if approved, would provide an important option for appropriate patients with COPD who are receiving ICS/LABA and require additional bronchodilation, avoiding the need for multiple inhalers.”
Mike Aguiar, CEO of Innoviva, Inc. said, “This positive opinion will lead to a significant therapeutic convenience for those appropriate patients already on ICS/LABA treatment that require additional bronchodilation. Trelegy is the latest development in our collaboration with GSK and is testament to our ongoing efforts to advance respiratory medicine.”
A CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission. A final decision by the European Commission is anticipated by around the end of 2017.
Regulatory applications have been submitted and are undergoing assessment in a number of other countries, including the US, Australia and Canada. FF/UMEC/VI is an investigational medicine not yet approved for use as a single inhaler triple therapy anywhere in the world. The proposed trade name ‘Trelegy Ellipta’ is subject to regulatory approval.
About COPD
COPD is a common but serious lung disease that is thought to affect around 384 million people worldwide.1
For people living with COPD, the inability to breathe normally can consume their daily lives and make simple activities, like walking up stairs, an everyday struggle.
Long-term exposure to inhaled 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.2
Every person with COPD is different, with different needs, different challenges and different goals. Understanding this and providing support to help meet these needs is the foundation of GSK’s work.
About the once-daily single inhaler triple therapy clinical programme in COPD supporting the European Marketing Authorisation Application
The European Marketing Authorisation Application for Trelegy Ellipta is supported by efficacy and safety data from the FF/UMEC/VI development programme, as well as data from studies with the components either alone, or in combination. Positive top-line results of the phase 3 FULFIL (Lung FUnction and quality of LiFe assessment in COPD with closed trIpLe therapy) study which investigated once-daily single inhaler triple therapy compared to twice-daily budesonide/formoterol were announced in June 2016 and published in 2017 (Lipson DA et al. Am J Resp Crit Care Med 2017).
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.
Trade marks are owned by or licensed to the GSK group of companies.
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®. 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.
SOURCE: Innoviva
Post Views: 131
LONDON, UK I September 15, 2017 I GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for fluticasone furoate/ umeclidinium/vilanterol (FF/UMEC/VI) as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist (for effects on symptom control see section 5.1). The proposed brand name is Trelegy Ellipta.
Trelegy Ellipta is a combination of an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA) and a long-acting beta2-adrenergic agonist (LABA), delivered once daily in GSK’s Ellipta dry powder inhaler. It is the first once-daily single inhaler triple therapy to be granted a positive opinion by the CHMP. The proposed strength is FF/UMEC/VI 100/62.5/25 mcg.
Patrick Vallance, GSK’s President, R&D, said, “We believe once-daily single inhaler triple therapy, if approved, would provide an important option for appropriate patients with COPD who are receiving ICS/LABA and require additional bronchodilation, avoiding the need for multiple inhalers.”
Mike Aguiar, CEO of Innoviva, Inc. said, “This positive opinion will lead to a significant therapeutic convenience for those appropriate patients already on ICS/LABA treatment that require additional bronchodilation. Trelegy is the latest development in our collaboration with GSK and is testament to our ongoing efforts to advance respiratory medicine.”
A CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission. A final decision by the European Commission is anticipated by around the end of 2017.
Regulatory applications have been submitted and are undergoing assessment in a number of other countries, including the US, Australia and Canada. FF/UMEC/VI is an investigational medicine not yet approved for use as a single inhaler triple therapy anywhere in the world. The proposed trade name ‘Trelegy Ellipta’ is subject to regulatory approval.
About COPD
COPD is a common but serious lung disease that is thought to affect around 384 million people worldwide.1
For people living with COPD, the inability to breathe normally can consume their daily lives and make simple activities, like walking up stairs, an everyday struggle.
Long-term exposure to inhaled 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.2
Every person with COPD is different, with different needs, different challenges and different goals. Understanding this and providing support to help meet these needs is the foundation of GSK’s work.
About the once-daily single inhaler triple therapy clinical programme in COPD supporting the European Marketing Authorisation Application
The European Marketing Authorisation Application for Trelegy Ellipta is supported by efficacy and safety data from the FF/UMEC/VI development programme, as well as data from studies with the components either alone, or in combination. Positive top-line results of the phase 3 FULFIL (Lung FUnction and quality of LiFe assessment in COPD with closed trIpLe therapy) study which investigated once-daily single inhaler triple therapy compared to twice-daily budesonide/formoterol were announced in June 2016 and published in 2017 (Lipson DA et al. Am J Resp Crit Care Med 2017).
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.
Trade marks are owned by or licensed to the GSK group of companies.
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®. 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.
SOURCE: Innoviva
Post Views: 131
