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MHRA supports the use of remdesivir as the first medicine to treat Coronavirus 

On behalf of MHRA


We would like to inform you that remdesivir has received a positive scientific opinion under the Medicines and Healthcare products Regulatory Agency (MHRA) Early Access to Medicines Scheme (EAMS) in the UK. This will allow remdesivir to be used in the treatment of adults and adolescents hospitalised with severe COVID-19 infection who meet additional clinical criteria.

EAMS was set up to give patients with life-threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation, but when there is a clear, unmet medical need.

This scientific opinion does not replace the normal licensing procedures for medicines but supports prescribers and patients to make a decision on whether to use the medicine before its licence is approved. As part of the scientific opinion, a framework to collect safety data and manage risks will be implemented.

Following advice from the Commission on Human Medicines, we issued this scientific opinion after a rigorous evaluation of the benefit/risk balance of the medicine, based on the emerging data available.

No specific treatment for COVID-19 is currently available and there is an urgent unmet need for the treatment of pandemic COVID-19. Early results from clinical studies particularly the NIAIDACTT-1 study as published in the New England Journal of Medicine (NEJM), have shown that remdesivir reduced the time of recovery from 15 days to 11 days inpatients with severe COVID-19 and possibly also reduced the proportion of people dying from COVID-19. The risks associated with remdesivir can be managed and do not outweigh the benefits.

Please see the scientificopinion or our pressrelease for more information.

KindRegards,
Patient, Public and Stakeholder Engagement team
Communications division 

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone: 0203 080 6000
Email: engagement@mhra.gov.uk


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4 Jul 2020
9:06 am