ViiV HEALTHCARE ANNOUNCES CHMP POSITIVE OPINION FOR VOCABRIA + REKAMBYS, THE FIRST AND ONLY COMPLETE LONG-ACTING HIV TREATMENT, FOR ADOLESCENTS IN EUROPE

Vocabria + Rekambys (cabotegravir + rilpivirine) is the first and only complete long-acting regimen for the treatment of HIV, reducing dosing days from 365 to 6 per year At just 65% globally, treatment coverage for 10 – 19-year-olds living with HIV is lagging behind UNAIDS’s target, demonstrating need to improve HIV care options for young people London, 16 December 2024 – 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 Europe Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for Vocabria (cabotegravir long-acting injections) in combination with Johnson & Johnson Innovative Medicine’s Rekambys (rilpivirine long-acting injections) for the treatment of HIV-1 infection in adolescents 12 years of age and older and weighing at least 35 kg who are virologically suppressed. As of 2023 there were 1.55 million young people aged 10 to 19 around the world living with HIV. 1 Advances in treatment mean HIV can be a manageable condition, but some people face challenges with taking daily oral regimens, including adherence, the daily reminder of HIV, and a fear of disclosure and associated stigma. 2 This expanded indication for cabotegravir and rilpivirine long-acting, if approved, will mark the first time a complete, long-acting regimen is available for adolescents living with HIV, who have lower reported treatment coverage, adherence to treatment and viral suppression rates than older age groups. 1 Harmony P. Garges, MD, Senior Vice President and Chief Medical Officer at ViiV Healthcare, said: "Today’s positive CHMP opinion is an important step towards bringing the first long-acting injectable regimen to adolescents living with HIV. Long-acting regimens have potential to provide effective HIV therapy and help address the challenges many people face taking daily oral regimens. This progress underscores our ongoing commitment to bringing more therapeutic options to young people as part of our mission to leave no person living with HIV behind.” The positive opinion is supported by week 24 data from the MOCHA study, (IMPAACT 2017, Study 208580), an ongoing Phase I/II multicentre, open-label, non-comparative study of the safety, tolerability and pharmacokinetics of cabotegravir and rilpivirine long-acting. Based on data from the study in 144 adolescents (aged at least 12 years and weighing 35kg or more), no new safety concerns were identified and 139 of 144 participants (96.5%) remained virologically suppressed (plasma HIV-1 RNA value <50 c/mL) at week 24. 3 Furthermore, 99% of participants asked at week 24 (139/141) stated that they preferred injectable long-acting medicines over daily orals, mainly for the convenience and burden reduction; the most prominent components of burden reduction were decrease in adherence-related stress and increased privacy. 4 Marketing Authorisation from the European Commission is anticipated in the coming months. Cabotegravir and rilpivirine long-acting, under the brand name Vocabria + Rekambys, was approved by the EMA for the treatment of HIV-1 in adults who are virologically suppressed in December 2020. About Vocabria Vocabria (cabotegravir) injection is indicated - in combination with rilpivirine injection - for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the non-nucleoside reverse transcriptase inhibitors (NNRTI) and integrase inhibitor (INI) class. Vocabria tablets are indicated - in combination with rilpivirine tablets - for the short-term treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class for: oral lead in to assess tolerability of Vocabria and rilpivirine prior to administration of long acting Vocabria injection plus long acting rilpivirine injection. oral therapy for adults who will miss planned dosing with Vocabria injection plus rilpivirine injection. Vocabria tablets are only indicated for treatment of HIV-1 in combination with rilpivirine tablets, therefore, the prescribing information for Edurant tablets should also be consulted for recommended dosing. Please consult the full Summary of Product Characteristics for all the safety information: Vocabria 400mg/600 mg prolonged-release suspension for injection and Vocabria 30 mg film-coated tablets About Rekambys Rekambys is indicated - in combination with cabotegravir injection - for the treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the NNRTI and INI class. Rekambys should always be co-administered with a cabotegravir injection. The prescribing information for cabotegravir injection should be consulted for recommended dosing. Rekambys may be initiated with oral lead-in or without (direct to injection). Please consult the full Summary of Product Characteristics for all the safety information: Rekambys 600mg/900 mg prolonged-release suspension for injection 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 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 . ViiV Healthcare enquiries: Media enquiries: Rachel Jaikaran +44 (0) 78 2352 3755 (London) Melinda Stubbee +1 919 491 0831 (North Carolina) GSK enquiries: Media: Tim Foley +44 (0) 20 8047 5502 (London) Sarah Clements +44 (0) 20 8047 5502 (London) Kathleen Quinn +1 202 603 5003 (Washington DC) Alison Hunt +1 540 742 3391 (Washington DC) Investor Relations: Annabel Brownrigg Gleeson +44 (0) 20 8047 5502 (London) James Dodwell +44 (0) 20 8047 2406 (London) Mick Readey +44 (0) 7990 339653 (London) Camilla Campbell +44 (0) 7803 050238 (London) Steph Mountifield +44 (0) 7796 707505 (London) Jeff McLaughlin +1 215 751 7002 (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 under Item 3.D “Risk factors” in GSK’s Annual Report on Form 20-F for 2023, and GSK’s Q3 Results for 2024. Registered in England & Wales: GSK plc ViiV Healthcare Limited No. 3888792 No. 06876960 Registered Office: 79 New Oxford Street ViiV Healthcare Limited London GSK Medicines Research Centre WC1A 1DG Gunnels Wood Road, Stevenage United Kingdom SG1 2NY References: UNICEF. Adolescent HIV treatment. Available at: https://data.unicef.org/topic/hivaids/adolescent-hiv-treatment. Last accessed December 2024. De Los Rios P, Okoli C, Castellanos C et al. Physical, Emotional and Psychosocial Challenges Associated with Daily Dosing of HIV Medications and Their Impact on Indicators of Quality of Life: Findings from the Positive Perspectives Study. AIDS and Behaviour. 2020. Gaur A et al. Long-Acting Cabotegravir Plus Rilpivirine In Adolescents With HIV: Week 24 IMPAACT 2017(MOCHA) Study. CROI 2024, Denver, abstract 188. Available at: Long-Acting Cabotegravir Plus Rilpivirine In Adolescents With HIV: Week 24 IMPAACT 2017(MOCHA) Study - CROI Conference. Last accessed December 2024. Lowenthal ED et al. IMPAACT 2017 Adolescent/Parent Experiences With LA Cabotegravir Plus Rilpivirine for HIV Treatment. CROI 2024, Denver, abstract 949. Available at: https://www.croiconference.org/abstract/impaact-2017-adolescent-parent-experiences-with-la-cabotegravir-plus-rilpivirine-for-hiv-treatment. Last accessed December 2024. ViiV Press Releases & Company Statements Media contacts For our corporate press office, email: Kate Senter OR call +44 7796 707446 For US-specific media enquiries, email: Rachel Jaikaran OR call +1 9193578932 Reporting of side effects If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the GSK Reporting Tool link https://gsk.public.reportum.com/. By reporting side effects, you can help provide more information on the safety of this medicine. If you are from outside the UK, you can report adverse events to GSK/ ViiV by selecting your region and market, here. Connect with us ViiV Healthcare 79 New Oxford Street London United Kingdom WC1A 1DG Tel: +44 20 8047 5000 Contact us Terms of use Cookie policy Privacy notice Modern Slavery Statement Sitemap All our locations Our Clinical Trial Register GSK.com Carbon Reduction Plan Corporate ethics and compliance Social Media at ViiV Healthcare NP-GBL-HVX-COCO-230027 April 2026 ©2021 ViiV Healthcare group of companies. All rights reserved. ViiV Healthcare UK Limited. Registered in England and Wales No. 06990358. YOU ARE LEAVING THE SITE You are about to leave a ViiV Healthcare website. By clicking this link, you will be taken to a website that is independent from ViiV Healthcare. The site you are linking to is not controlled or endorsed by ViiV Healthcare and ViiV Healthcare is not responsible for the content provided on that site. NP-GBL-HVX-COCO-220042 | November 2021 Cancel Accept Select Country & Language Global English Australia English Canada English Français España Español France Français Germany Deutsch Italy Italiano Japan 日本語 Netherlands Nederlands United States English You are accessing historic archive material This is an archived press release which may not reflect current medical knowledge and should not be used as a source of information on the present label, safety data or efficacy data for ViiV Healthcare products and/or their uses. Please refer to your nationally approved label or summary of product characteristics for up-to-date product information. I understand

The release as fetched from its publisher. viivhealthcare.com ↗