Veklury (remdesivir) recommended by NICE for treatment of COVID-19 in vulnerable adults and children

Veklury (remdesivir) recommended by NICE for treatment of COVID-19 in vulnerable adults and children

• Remdesivir is the first antiviral treatment recommended by NICE to treat eligible children, including those with a high risk of serious illness from COVID-19.[i]^,[ii]
• This decision secures long-term access to remdesivir in the UK, further to conditional authorisation being granted in 2020, which enabled use of the therapy during the early part of the pandemic.[iii]

Tuesday 9^th April 2024, London, UK – Gilead Sciences Ltd. today announced that the National Institute of Health and Care Excellence (NICE) has published final draft guidance recommending use of remdesivir for treating COVID-19 in eligible adults and children.[iv] Specifically, the treatment is indicated for hospitalised adults and children weighing at least 40kg and at a high risk of serious illness. Remdesivir is also recommended within its marketing authorisation for treating COVID-19 in children at least 4 weeks of age and weighing at least 3 kg who are in hospital with pneumonia requiring supplemental oxygen.⁴

Prof Andrew Ustianowski, infectious diseases physician and previous Clinical Lead for the NIHR COVID Vaccine Research Programme, says: “COVID-19 continues to present a significant challenge in hospital settings, particularly for people who are immunocompromised or have comorbidities, such as some cancers, and have an increased risk of infection. The recommendation for use of remdesivir via the NHS provides treating clinicians with an additional treatment option that may benefit many vulnerable patients, including young, immunocompromised children.”

COVID-19 remains a serious health concern across the UK. In England alone, the virus continues to contribute to thousands of people being admitted to hospital each week, and over 1,000 deaths with COVID-19 on the death certificate registered in February 2024.[v] Certain groups of people are at a higher risk of getting seriously ill from COVID-19, including those with certain types of cancer; autoimmune or inflammatory conditions; severe kidney or liver disease; conditions affecting the brain or nervous system; and more.[vi] Remdesivir has been shown to significantly reduce mortality in immunocompromised individuals hospitalised with COVID-19, as well as in those requiring low flow oxygen supplementation.[vii]^,[viii]

Julian Cole, Country Medical Director, Gilead UK & Ireland, says: “When the COVID-19 pandemic first began, Gilead reacted quickly to develop remdesivir as a potential treatment option. Through an early access to medicine scheme, remdesivir was used in almost every UK NHS acute hospital at the height of the pandemic. NICE rightly needed to assess this treatment in a non-pandemic setting and we welcome today’s news, which provides clinicians continuity and the option for sustained use of remdesivir on the NHS. We are committed to supporting patients and communities fighting COVID-19 and other infectious diseases, and we were pleased to collaborate with NICE, NHS England and other stakeholders to provide access to this treatment.” 

[i] NICE. 2023. Therapeutics for people with COVID-19 [ID4038]. Available at https://www.nice.org.uk/guidance/indevelopment/gid-ta10936. Accessed April 2024.

[ii] Electronic Medicines Compendium. 2022. Veklury 100mg powder for concentrate for solution for infusion SmPC. Available at  https://www.medicines.org.uk/emc/product/11597/smpc. Accessed April 2024.

[iii] GOV.uk. Early access to medicines scheme (EAMS) scientific opinion: Remdesivir in the treatment of patients hospitalised with suspected or laboratory-confirmed SARS-CoV-2 infection who meet the clinical criteria. Available at: https://www.gov.uk/government/publications/early-access-to-medicines-scheme-eams-scientific-opinion-remdesivir-in-the-treatment-of-patients-hospitalised-with-suspected-or-laboratory-confirme. Accessed April 2024.

[iv] NICE Final Draft Guidance - Remdesivir and tixagevimab plus cilgavimab for treating COVID-19. Available at https://www.nice.org.uk/guidance/gid-ta11297/documents/674. Accessed April 2024.

[v] COVID-19 in England. Key fact available at: UKHSA data dashboard. Available at: https://ukhsa-dashboard.data.gov.uk/. Accessed April 2024.

[vi] NHS. Treatments for COVID-19. Available at https://www.nhs.uk/conditions/covid-19/treatments-for-covid-19/. Accessed April 2024.

[vii] Mozaffari, E., et al. Remdesivir is associated with reduced mortality in COVID-19 patients requiring supplemental oxygen including invasive mechanical ventilation across SARS-CoV-2 variants. in Open Forum Infectious Diseases. 2023. Oxford University Press US.

[viii] Mozaffari E, Chandak A., et al. Remdesivir Reduced Mortality in Immunocompromised Patients Hospitalized for COVID-19 Across Variant Waves: Findings From Routine Clinical Practice. Clin Infect Dis. 2023 Dec 15;77(12):1626-1634. doi: 10.1093/cid/ciad460.

Remdesivir was the first medicine for COVID-19 to receive full Marketing Authorisation in 2022.[ix] It has been available since a conditional licence was granted in 2020 via an Early Access Medicines Scheme.³ This new guidance from NICE means that remdesivir enters routine commissioning as the only antiviral recommended in England, Wales, Scotland, and Northern Ireland for adult patients with COVID-19 requiring supplemental oxygen, and for patients younger than 12.^1,2

[ix] NHS England. Interim Clinical Commissioning Policy: Remdesivir for patients hospitalised due to COVID-19. Available at: Coronavirus » Interim Clinical Commissioning Policy: Interim Clinical Commissioning Policy: Remdesivir for patients hospitalised due to COVID-19 (england.nhs.uk). Accessed April 2024.

About remdesivir

Remdesivir is indicated for the treatment of coronavirus disease 2019 (COVID-19) in:

• adults and paediatric patients (at least 4 weeks of age and weighing at least 3 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment).²
• adults and paediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.²

Refer to the remdesivir Summary of Product Characteristics (SmPC) for a full list of adverse events and the complete important safety information.²

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.