The first triple therapy for COPD, in one single device Trelegy Ellipta, is approved in China

GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced that Trelegy® Ellipta® (fluticasone furoate/umeclidinium/vilanterol 'FF/UMEC/VI') has been approved for launch in China by the National Medical Products Administration (NMPA). TRELEGY ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), once daily.

Trelegy Ellipta is the latest breakthrough for the management of the chronic obstructive pulmonary disease (COPD). Trelegy Ellipta is the first once-daily single inhaler triple therapy to be approved in China. It 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 device. 

In FULFIL study, Trelegy Ellipta provided meaningful and statistically significant improvements in lung function, health-related quality of life and exacerbation vs a commonly used ICS/LABA regimen in clinical practice1

In IMPACT study, a phase-III clinical trial which involved 10355 patients, Trelegy Ellipta was superior to corresponding dual therapies, including inhaled corticosteroid/long-acting beta2-adrenergic agonist (ICS/LABA) and long-acting muscarinic antagonist/long-acting beta2-adrenergic agonist (LAMA/LABA), on multiple clinically important endpoints, including reducing acute excerbations, improving lung function and  health related quality of life2. 

More importantantly Trelegy Ellipta is the only Triple Therapy that demonstrated a reduction in hospitalision due to the exacerbation of COPD and a reduction in the risk of all-cause mortality compared with a LAMA/LABA2 .

Professor Zhong Nanshan, Academician of Chinese Academy of Engineering, said: "COPD is a very common, serious and debilitating lung disease which, like hypertension or diabetes, needs the standardised treatment on a long-term basis to keep the condition stable. Research shows that a combination of ICS/LAMA/LABA for COPD can effectively alleviate patients' symptoms and reduce the risk of acute exacerbation. A triple combination (like Trelegy Ellipta) has more significant benefits for a considerable number of COPD patients corresponding LAMA/LABA2 and commonly used ICS/LABA regimen1."

The latest data shows that ~100 million Chinese patients are living with COPD. Moreover, the prevalence has significantly increased in recent years from 8.2% in 2002 to 13.7% for people at 40 and older3,4. Due to the low awareness and the low diagnosis rate for the disease, COPD has become the third leading cause of death by disease in China, presenting a huge public health challenge5

Dr. Fabio Landazabal, Senior Vice President of Emerging Markets and Chairman of GSK China, said: “ Trelegy Ellipta is the first innovative medicine to be approved in China that delivers three strong and effective molecules in a once-daily single inhalation. As Global leaders in respitarory, we are committed to improve the management of the respiratory diseases and dedicated to provide individualised therapies for Chinese patients. We will spare no effort to make Trelegy Ellipta available throughout the country and enable Chinese COPD patients to benefit from this innovative therapy as soon as possible."

ELLIPTA

Trelegy is delivered via the innovative ELLIPTA inhaler, meaning that treatment can be adjusted without having to switch inhalers, with fewer patients reporting critical errors compared with other inhalers6 or other multiple inhalers7. Furthermore, ELLIPTA is associated with less inhaler teaching time compared to other commonly used inhalers6 or other multiple inhalers7.

Last but not least, ELLIPTA provides accurate dosing through its consistent dose delivery that can be achieved even by patients with COPD with low inspiratory airflow8.

Safety Information for FF/UMEC/VI

Studies have shown that the adverse-event profiles of FF/UMEC/VI were similar to that of  ICS/LABA and LAMA/LABA comparators, and there were no new safety findings associated

with the use of an inhaled glucocorticoid,a LAMA, or a LABA in combination1,2.

GSK’s commitment to respiratory disease

For 50 years, GSK has led the way in developing medicines that advance the management of asthma and COPD. From introducing the world’s first selective short-acting beta agonist in 1969, to launching six treatments in five years to create today’s industry-leading respiratory portfolio, we continue to innovate so we can reach the right patients, with the right treatment. Working together with the healthcare community, we apply world-class science to discover and understand the molecules that become the medicines of tomorrow. We won’t stand still until the simple act of breathing is made easier for everyone.

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

Trade marks are owned by or licensed to the GSK group of companies.

Innoviva – Innoviva is focused on royalty management. Innoviva's portfolio is anchored by the respiratory assets partnered with Glaxo Group Limited (GSK), including RELVAR®/BREO® ELLIPTA®, ANORO® ELLIPTA® andTRELEGY® 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® and ANORO® ELLIPTA®. In addition, Innoviva retains a 15 percent economic interest in future payments made by GSK for TRELEGY® ELLIPTA® and earlier-stage programs partnered with Theravance Biopharma, Inc. For more information, please visit Innoviva's website at www.inva.com.

GSK enquiries:

China: Summer Li  summer.n.li@gsk.com

 

References:

  1. Lipson DA, et al. Am J Respir Crit Care Med. 2017 Aug 15;196(4):438-446.
  2. Lipson DA, et al. N Engl J Med. 2018;378:1671–1680
  3. Zhong N, et al. Am J Respir Crit Care Med. 2007;176(8):753-760.
  4. Wang C. et al. The Lancet 2018; 391 (10131).
  5. Zhou M, et al. Lancet. 2019 Jun 24. pii S0140-6736(19)30427-1.
  6. van der Palen J, et al. NPJ Prim Care Respir Med. 2016;26:16079
  7. van der Palen J, et al. Int J Chron Obstruct Pulm Dis. 2018;13:2515–2523.
  8. Grant AC, et al. J Aerosol Med Pulm Drug Deliv. 2015;28:474–485.