|
PRESS RELEASE
ViiV HEALTHCARE RECEIVES EU MARKETING AUTHORISATION 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 authorisation is an important step to meet ViiV Healthcare’s commitment to bring paediatric formulations to children living with HIV
London, 22 February 2023 – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced the European Commission has granted 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 14 kg to <25 kg with human immunodeficiency virus type 1 (HIV-1). This authorisation includes the label extension of Triumeq tablet, lowering the minimum weight that a child with HIV-1 can be prescribed this medicine from 40 kg to 25 kg.
Despite significant advances in HIV treatment and care, only 52% of children living with HIV (under 14 years old) had access to optimised paediatric formulations of antiretrovirals in 2021.[i] The EU Marketing Authorisation follows the US Food and Drug Administration (FDA) approval of Triumeq PD in 2022. This provides access to age-appropriate formulations of dolutegravir for a younger population and helps to close the gap between HIV treatment options available for adults and children living with HIV.
Deborah Waterhouse, CEO at ViiV Healthcare, said: “Today, we are delighted to have received the EU Marketing Authorisation for Triumeq PD, expanding the options for child-friendly HIV treatments available in Europe. At ViiV Healthcare, we are committed to pushing the boundaries to develop medicines that address the unmet needs of the estimated 1.7 million children living with HIV, bringing us closer to achieving our mission of ensuring no one living with HIV – regardless of their age - is left behind.”
Amanda Ely, CEO at Chiva said: “Currently, young children face significant challenges due to limited age-appropriate treatment and therefore fewer children are achieving viral suppression, compared to adults.1 Through improved treatment options, increased access, and community support, we can increase the number of children living with HIV achieving viral suppression. Furthermore, by successfully initiating young children onto age-appropriate treatments, it can help them foster a positive relationship with their lifelong treatment regimen early on.”
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.
Please see the Important Safety Information (ISI) available at: Triumeq 50 mg/600 mg/300 mg film-coated tablets - Summary of Product Characteristics (SmPC) - (emc) (medicines.org.uk)
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
ViiV Healthcare enquiries: |
|
|
|
Media enquiries: |
Rachel Jaikaran |
+44 (0) 78 2352 3755 |
(London) |
|
Audrey Abernathy |
+1 919 605 4521 |
(North Carolina) |
GSK enquiries: |
|
|
|
Media enquiries: |
Tim Foley |
+44 (0) 20 8047 5502 |
(London) |
|
Simon Moore / Dan Smith |
+44 (0) 20 8047 5502 |
(London) |
|
Kathleen Quinn |
+1 202 603 5003 |
(Washington DC) |
|
Lyndsay Meyer |
+1 202 302 4595 |
(Washington DC) |
|
Alison Hunt |
+1 540 742 3391 |
(Washington DC) |
|
|
|
|
Investor Relations: |
Nick Stone |
+44 (0) 7717 618834 |
(London) |
|
James Dodwell |
+44 (0) 20 8047 2406 |
(London) |
|
Mick Readey |
+44 (0) 7990 339653 |
(London) |
|
Josh Williams |
+44 (0) 7385 415719 |
(London) |
|
Camilla Campbell
Steph Mountifield
Jeff McLaughlin |
+44 (0) 7803 050238
+44 (0) 7796 707505
+1 215 751 7002 |
(London)
(London)
(Philadelphia) |
|
Frannie DeFranco |
+1 215 751 4855 |
(Philadelphia) |
|
|
|
|
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 Q4 Results for 2022 and any impacts of the COVID-19 pandemic.
Registered in England & Wales:
GSK plc ViiV Healthcare Limited
No. 3888792 No. 06876960
Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
Media contacts
Thomas Jenkins
thomas.x.jenkins@viivhealthcare.com
ViiVHC Globalcomms
viivhc.globalcomms@viivhealthcare.com
Source: https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2023/february/viiv-healthcare-receives-eu-marketing-authorisation/
"Reproduced with permission - ViiV Healthcare"
ViiV Healthcare
For more HIV and AIDS News visit...
Positively Positive - Living with HIV/AIDS:
HIV/AIDS News |
