GSK Anoro Ellipta, a new once-daily dual bronchodilators treatment for COPD approved in China
20 March 2018
GSK and Innoviva, Inc. (Innoviva) today announced that a new once-daily dual bronchodilators treatment for chronic obstructive pulmonary disease (COPD) has been approved by the China Food and Drug Administration (CFDA). Anoro Ellipta (Umeclidinium/Vilanterol) is indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).
Anoro Ellipta is a combination of two bronchodilators in a single dry powder inhaler, the Ellipta. It contains umeclidinium (UMEC), a long-acting muscarinic antagonist (LAMA) and vilanterol (VI), a long-acting beta2 agonist (LABA). The approved dose of UMEC/VI is 62.5mcg/ 25mcg.
Professor Nanshan Zhong, Leading Principal Investigator for China Anoro Phase Ⅲ study and Academician of the Chinese Academy of Engineering said: “COPD affects more than 43 million people in China, many of whom experience a variety of symptoms associated with the disease. The disease represents a significant burden for these symptomatic patients. Therefore, it’s important to use ideal bronchodilators to optimise lung function in COPD treatment, so as to enhance patients’ quality of life and health status. We are pleased that Anoro Ellipta is now available for appropriate COPD patients for whom a once-daily dual bronchodilators in a single inhaler may be appropriate.”
Dr. James He, VP and Country Medical Director for GSK China said: “Study has confirmed that 40 to 50 per cent of COPD patients are still symptomatic although they were receiving LABD monotherapy1, which increase patients’ disease burden. Therefore, it’s important to use dual bronchodilators to further improve lung function and reduce symptoms for appropriate COPD patients to improve their quality of life. Our goal at GSK is to provide physicians with an expanded range of COPD medicines which enable a patient-centric approach to treatment, as recommended by COPD guidelines.”? ?
The clinical program for Anoro Ellipta included 9,329 subjects with COPD in five
6-month lung function trials, one 12-month long-term safety study, and 9 other trials of shorter duration. These clinical findings showed that Anoro Ellipta had significant advantages in improving lung function, symptoms and health status, and decreasing COPD exacerbation in comparison with placebo or single bronchodilator*. Meanwhile, it has a good safety and tolerance profile. Another 6-month clinical study including 580 patients (among whom 380 are Chinese patients) in Asia also showed the same results.
"We are delighted that the long-standing collaboration between Innoviva and GSK to develop respiratory medicines that meet patient needs has led to today’s launch of Anoro Ellipta in China. This development provides healthcare professionals with a new option to consider for appropriate COPD patients,” said Dr. Theodore J. Witek Jr., Senior Vice President and Chief Scientific Officer of Innoviva, Inc.
* The single bronchodilator used in the study was tiotropium bromide 18mcg q.d.
As part of the ‘in China, with China, for China’ strategy, GSK China has:
- Announced innovative antiretroviral Single Tablet Regimen Triumeq was officially launched in January 2018.
- Supported the launch of “New Respiration and Frequent Care” online management platform for asthma patients in December 2017.
- Supported the launch of the UK-China Health and Economy Partnership in November 2017.
- Supported the launch of "Happy Breath", COPD Tiered Diagnosis and Treatment Project across China in November 2017.
- Announced Flixotide Nebules received approval for the treatment of children asthma in September 2017.
- Announced partnership with Ali Health to launch innovative online service platform to improve adult vaccination consultation experience in Aug 2017.
- Announced innovative antiretroviral?Single Tablet Regimen Triumeq received approval in China in Aug 2017.
- Announced Cervarix, first vaccine for cervical cancer prevention in mainland China, was officially launched in July 2017.
- Announced the collaboration programme to aid hepatitis prevention and treatment in poverty-stricken areas of the western region in July 2017.
- Announced Seroxat CR and Tykerb on the list of reimbursed drugs as results of the national health insurance negotiations in July 2017.
- Announced a strategic partnership with academia to co-develop health big-data system and upgrade the management of respiratory diseases in June 2017.
- Aided the National Preventive Vaccination Services and Management Training Programme, helmed by the Chinese Preventive Medicine Association under the guidance of the National Health and Family Planning Commission, with the support of the China Centre for Disease Control and Prevention that officially kicked off in June 2017.
- Announced Viread, Arixtra, Requip and Mivacron included in the “2017 National Reimbursement Drug List” in Mar 2017.
GSK – a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com.
Innoviva, Inc. – Innoviva, formerly known as Theravance, Inc.,?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. For more information, please visit Innoviva’s?website at?www.inva.com. RELVAR?, BREO?, ANORO? and ELLIPTA? are trademarks of the GlaxoSmithKline group of companies.
GSK commitment to China
We are a science-led global healthcare company. We research, develop and manufacture a wide range of medicines, vaccines and consumer healthcare products. People are at the heart of what we do. We strive to bring high quality, high performing products to everyone who needs them. Creating innovative products and improving access to them is critical to our mission, allowing us to help build stronger, healthier communities. In China, and around the world, we are on a mission to help people do more, feel better, live longer. We are in China, with China, for China, and our commitment remains unwavering.
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Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Principal risks and uncertainties' in the company's Annual Report on Form 20-F for 2016.
- Müllerová H et al. PLoS One. 2014;9:e85540
- Dransfield MT et al. Prim Care Respir J. 2011; 20:46-53