UK – MHRA supports the use of remdesivir as the first medicine to treat COVID-19 in the UK

MHRA has today given the first positive scientific opinion under the Early Access to Medicines Scheme (EAMS) for use of Gilead’s remdesivir.

This step will support the use of remdesivir in the treatment of adults and adolescents hospitalised with severe coronavirus (COVID-19) infection who meet additional clinical criteria.

EAMS was set up by the MHRA to give patients with life-threatening or seriously debilitating conditions access to medicines that are not yet licenced, but when there is a clear, unmet medical need. The MHRA has delivered this scientific opinion after a rigorous evaluation of the benefit/risk balance of the medicine, based on the data available.

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…