GSK’s innovative antiretroviral Single Tablet Regimen Triumeq receives approval in China (1)

GSK today announced that Triumeq (generic name: dolutegravir, abacavir and lamivudine all-in-one tablet), the innovative antiretroviral (ARV) drug by its subsidiary joint venture ViiV Healthcare1, was granted approval by the China Food and Drug Administration (CFDA). Triumeq is a new Single Tablet Regimen (STR) ARV which will offer Chinese people living with HIV/AIDS the convinence of a single-pill once-a-day regimen. Triumeq was granted priority review by the CFDA as a new HIV drug.

Triumeq, the only 3-in-1 ARV that contains dolutegravir (DTG), is highly effective and well-tolerated. It poses a high barrier to drug resistance, few drug-drug interaction and administered as a single once daily tablet. Triumeq significantly reduces the pill burden on patients, enhances patient drug adherence, and significantly improves patients' quality of life.

Thirty years ago, AIDS was a fatal disease; with the joint efforts of physicians and scientists over the past decades, there has been considerable progress in terms of HIV/AIDS treatment, and AIDS is becoming a chronic disease that can be brought under full control.

Dr. Wim Swyzen, VP & Country Medical Director for GSK China and Hong Kong, said: "Through the availabaility of effective ARVs, we see patients having similar life expectancy compared to healthy age groups. Drug adherence and convenience are increasingly important factors in further enhancing the quality of life of people living with HIV/AIDS. Currently, there are no STR ARVs approved for use in China. CFDA's approval of Triumeq fills this gap and satisfies the pressing needs of patients seeking greater convenience with their drug regimens.

“We’ve seen very positive signals by the CFDA in the area of regulatory reform, and we’ll continue to strengthen our R&D activities in China and work hard to ensure that our pipeline of innovative HIV medicines, such as 2-in-1 ARV and long-acting agents, can be brought to China to benefit Chinese patients in the near future.”

Triumeq has been approved in more then 70 countries around the world and has been recommended by many international treatment guideline as the first-line priority therapy for HIV naïve patients.2,3

Triumeq’s approval follows the launch of Tivicay, another ARVs, by GSK last year. GSK has been providing high-quality HIV/AIDS medications to Chinese patients since 1999, when Combivir was approved as the first drug for the treatment of HIV/AIDS in China.

As of 30 June 2016, the number of known HIV/AIDS patients in China stood at 627,030, with 194,435 cases reported to have died from the condition. 421,911 patients are currently undergoing antiviral therapy.4

Before the World AIDS Day last year, GSK China joined hands with the Home of Red Ribbon in Beijing on the "Care for AIDS Patients" campaign, which called on society to be more concerned, understanding, and supportive of patients living with HIV and AIDS. GSK has also supported the "Red Ribbon Health Ambassador" campus programme that seeks to create greater awareness of the importance of HIV prevention, especially among young students, in order to control the spread of HIV. The programme was organised by institutions such as the National Health and Family Planning Commission, the Central Committee of the Communist Youth League of China, the State Council Office of AIDS Prevention and Control, and the Chinese Association of STD and AIDS Prevention and Control and held in 16 major universities nationwide.

As part of the ‘in China, with China, for China’ strategy, GSK China has:

  • 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.
  • Joined hands with the Home of Red Ribbon to combat HIV/AIDS, unveiling plan to support people living with HIV in Nov 2016.
  • Announced the strategic partnership with China Preventive Medicine Association (CPMA) to address major public health challenges in China in Nov 2016.
  • Announced the approval of Cervarix in China to help protect women from cervical cancer in July 2016.
  • Announced a Memorandum of Understanding between the GSK Institute for Infectious Diseases and Public Health and Tsinghua University to tackle global public health challenges in June 2016.
  • Launched Tivicay, an innovative HIV drug, in June 2016.
  • Participated in the national price negotiation pilot and announced a price reduction of our first line chronic hepatitis B treatment, Viread, by up to 67% in May 2016.
  • Announced a Beijing-based Institute for Infectious Disease and Public Health to conduct local development programmes for pivotal HIV and TB R&D assets in March 2016.
  • Partnered with the National Health and Family Planning Commission on a multi-year programme to fund independent training programmes in Hepatitis and COPD for over 13,000 healthcare professionals from September 2015.
  • Formalised a partnership with Shanghai-based Desano Pharmaceuticals to locally manufacture the Active Pharmaceutical Ingredient for Tivicay (dolutegravir) in July 2015.
  • Transformed our commercial operating model to actively contribute to improving the quality of scientific exchanges with healthcare professionals for the benefit of patients since May 2015.

 

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.

 

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.

 

GSK enquiries:

Susan Song            susan.s.song@gsk.com      (China)

 

References:

1. ViiV Healthcare, a joint venture in which GSK is the majority shareholder, is a global specialist HIV company.

2. DHHS Adult/Adolescent Guidelines. updated Apr 6, 2015

3. Günthard H et al. JAMA 2014; 312:410-25; EACS Guidelines Version 7.1 November 2014

4. Journal of China HIV/AIDS, Issue 8, No 22, Aug 2016

 

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.