Trelegy Ellipta, the world’s first once-daily triple therapy for the maintenance treatment of COPD officially launched in China

GlaxoSmithKline (LSE/NYSE: GSK) announced today that the Trelegy® Ellipta® (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’), the first once-daily single inhaler triple therapy for chronic obstructive pulmonary disease (COPD) is officially launched in China.

The launch follows the product’s recent approval by the National Medical Products Administration (NMPA). Trelegy Ellipta is indicated for the maintenance treatment of patients with COPD. Trelegy is a combination of an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA) and a long-acting beta2-adrenergic agonist (LABA), delivering once daily in GSK’s Ellipta dry powder inhaler device.

China has approximately 100 million COPD patients1. Moreover, the prevalence has significantly increased in recent years from 8.2% in 2002 to 13.7% in 2015 for people at 40 and older1,2. 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 challenge3.

Dr. James He, Vice President and Head of Medical affairs of GSK China: “We are delighted that Trelegy Ellipta could be available in China as this will enable more COPD patients to benefit from this world-leading therapy. This is a significant milestone as healthcare professionals now have a new once-daily single-inhaler triple therapy option to consider for their patients with COPD. The latest therapy clinical study indicates that Trelegy Ellipta can provide meaningful and statistically significant improvements in lung function, health-related quality of life and exacerbation compared with a commonly used ICS/LABA regimen4. Moreover, Trelegy Ellipta will be a very valuable option for patients considering its unique reduction in the risk of all-cause mortality compared with LAMA/LABA regimen5.”

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 COPD patients versus corresponding LAMA/LABA2 and a commonly used ICS/LABA regimen4." 

Dr. Fabio Landazabal, Senior Vice President of Emerging Markets at GSK, said: “Trelegy ELLIPTA is the only once-daily single-inhaler triple therapy to reduce hospitalisations
and the risk of all-cause mortality compared with a LAMA/LABA5, Also Trelegy ELLIPTA has proven superiority vs a current commonly used ICS/LABA on improvement of symptoms and lung function and reduction of exacerbations of COPD patients4. GSK is committed to improving the health and quality of human life through R&D and innovation, and is leading the way to help patients do more, feel better and live longer.”

Trelegy Ellipta is supported by data from the FF/UMEC/VI development programme, as well as data from studies with FF, UMEC and VI either alone or in combination. Trelegy will enter China market from January 2020. GSK will do relentless endeavour to make Trelegy accessible to more Chinese COPD patients that allow them to benefit from this innovative therapy as soon as possible.

The Summary of Product Characteristics is available at www.gsk.com.

 

ELLIPTA

Trelegy is delivered via the innovative ELLIPTA inhaler, meaning that treatment can be inhaled 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 time7 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 combination4,5

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 – 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.

 

GSK enquiries:

China: Summer Li  summer.n.li@gsk.com

 

References

  1. Wang C, Xu J, Yang L, et al. Prevalence and risk factors of chronic obstructive pulmonary disease in China (the China Pulmonary Health [CPH] study): a national cross-sectional study. The Lancet 2018; 391: 1706-17.
  2. Zhong N, et al. Am J Respir Crit Care Med. 2007;176(8):753-760.
  3. Zhou M, et al. Lancet. 2019 Jun 24. pii S0140-6736(19)30427-1.
  4. Lipson DA, et al. Am J Respir Crit Care Med. 2017 Aug 15;196(4):438-446.
  5. Lipson DA, et al. N Engl J Med. 2018;378:1671–1680.
  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.