ViiV HEALTHCARE ANNOUNCES CHMP POSITIVE OPINION FOR TRIUMEQ PD, THE FIRST DISPERSIBLE SINGLE TABLET REGIMEN CONTAINING DOLUTEGRAVIR, A ONCE-DAILY TREATMENT FOR CHILDREN LIVING WITH HIV IN EUROPE

  • Triumeq PD is the first dispersible single tablet regimen containing dolutegravir for children living with HIV
  • The positive opinion follows FDA approval for Triumeq PD in March 2022

London, 16 December 2022– ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for Triumeq PD, a dispersible tablet formulation of the fixed dose combination of abacavir, dolutegravir and lamivudine for the treatment of paediatric patients weighing 14kg to <25 kg with human immunodeficiency virus type 1 (HIV-1). The CHMP’s positive opinion includes the label extension of Triumeq tablet, lowering the minimum weight that a child with HIV-1 can be prescribed this medicine from 40kg to 25kg.1

UNAIDS’ latest data indicates that globally only half (52%) of children living with HIV are on anti-retroviral treatment (ART), lagging far behind adults, where three quarters (76%) are receiving ART.2 The widening gap between children and adults propels the importance of available age-appropriate treatment options to ensure children can access optimal care.

Deborah Waterhouse, CEO of ViiV Healthcare, said: “Around the world today, an estimated 1.7 million children are currently living with HIV3. We know that children and young people living with HIV have specific treatment needs, and options that work for them can be limited. Today’s CHMP positive opinion brings us one step closer to closing that treatment gap, and ensure we leave no one living with HIV behind.”

Amanda Ely, CEO of Chiva said: “Despite significant advances in HIV treatment, more child-friendly formulations are urgently needed for the survival of children living with HIV globally. The combination of appropriate paediatric treatment and community-led support will help to ensure improved diagnosis, rapid treatment initiation and importantly, help ensure that the lifelong treatment needs of children and young people growing up with HIV are supported in order for them to live well and thrive.”

The CHMP’s positive opinion follows the US Food and Drug Administration (FDA) approval earlier this year.

Notes to editors:

About Triumeq

Triumeq is a fixed-dose combination containing the INSTI dolutegravir and the NRTIs abacavir and lamivudine.

Two essential steps in the HIV life cycle are replication – when the virus turns its RNA copy into DNA – and integration – the moment when viral DNA becomes part of the host cell’s DNA. These processes require two enzymes called reverse transcriptase and integrase. NRTIs and integrase inhibitors interfere with the action of the two enzymes to prevent the virus from replicating and further infecting cells.

Trademarks are owned by or licensed to the ViiV Healthcare group of companies.

 About ViiV Healthcare

ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of acquiring HIV. Shionogi became a ViiV shareholder in October 2012. The company’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.

For more information on the company, its management, portfolio, pipeline, and commitment, please visit www.viivhealthcare.com.

About GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com/company

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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 in the Company's Annual Report on Form 20-F for 2021, GSK’s Q3 Results for 2022 and any impacts of the COVID-19 pandemic.

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References

  1. European Medicines Agency. Triumeq Summary of Opinion. Available at: https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-12-15-december-2022. Last accessed December 2022.
  2. In Danger: UNAIDS Global AIDS Update (2022). Available at https://www.unaids.org/en/resources/documents/2022/in-danger-global-aids-update. Last accessed December 2022.
  3. UNAIDS DATA 2022. Available at https://www.unaids.org/sites/default/files/media_asset/JC3032_AIDS_Data_book_2021_En.pdf. Last accessed December 2022.

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Reporting of side effects

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