COVID-19
Remdesivir will be used to treat those hospitalised with severe COVID-19 infections.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today approved an anti-viral drug Remdesivir under the Early Access to Medicines Scheme (EAMS) as the first medicine to treat COVID-19.
The move will allow the use of remdesivir in the treatment of adults and adolescents hospitalised with severe COVID-19 infection who meet a specific 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 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.
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.
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.”
