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. Following expert advice from the Commission on Human Medicines and the Expert Working Group on COVID-19, 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.
Remdesivir’s current use in the UK will be for patients in cases of high unmet medical need determined by a physician through the EAMS, where it will be provided to the NHS free of charge by Gilead throughout the EAMS period. It will also continue to be used in clinical trials. Several clinical trials to evaluate remdesivir and its possible effects on patients with COVID-19 have already been approved by the MHRA and are ongoing in the UK.
Dr June Raine, MHRA Chief Executive, said:
We are committed to ensuring that patients can have fast access to promising new treatments for COVID-19. We will continue to work closely with the Department of Health and Social Care and other healthcare partners on protecting public health in the UK by prioritising our essential work on clinical trials, access to medicines, and the development of vaccines.