ViiV Healthcare receives complete response letter from US FDA for use of investigational cabotegravir and rilpivirine long-acting regimen in the treatment of HIV

London, 21 December 2019 – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its application for cabotegravir and rilpivirine long-acting regimen for treatment of HIV-1 infection in virologically suppressed adults. The reasons given in the CRL relate to Chemistry Manufacturing and Controls (CMC). There have been no reported safety issues related to CMC and there is no change to the safety profile of the products used in clinical trials to date. ViiV Healthcare will work closely with the FDA to determine the appropriate next steps for this New Drug Application. Cabotegravir is an integrase strand transfer inhibitor developed by ViiV Healthcare and rilpivirine is a non-nucleoside reverse transcriptase inhibitor developed by Janssen Sciences Ireland UC. The cabotegravir and rilpivirine long-acting regimen is an investigational product and not approved anywhere in the world. About ViiV Healthcare ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (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 becoming infected with HIV. Shionogi joined in October 2012. The company’s aim is to take a deeper and broader interest in HIV/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 science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com. 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 2018. ViiV Healthcare Media enquiries: Audrey Abernathy +1 919 605 4521 Stephen Rea +44 (0) 78 8126 9009 GSK Global Media enquiries: Simon Steel +44 (0) 20 8047 5502 Analyst/Investor enquiries: Kathleen Quinn Sarah Elton-Farr +1 202 603 5003 +44 (0) 20 8047 5194 Danielle Smith James Dodwell +44 (0) 20 8047 0932 +44 (0) 20 8047 2406 Jeff McLaughlin +1 215 751 7002 This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014. The person responsible for arranging the release of this announcement on behalf of GSK is V.A. Whyte, Company Secretary. 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

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