The MHRA opinion will support the use of remdesivir to treat patients hospitalised with severe Covid-19 infection who meet additional clinical criteria
MHRA allows use of remdesivir for Covid-19 treatment in UK. (Credit: PIRO4D from Pixabay.)
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted the first positive scientific opinion for Gilead’s remdesivir to treat Covid-19 in the UK.
The positive opinion, delivered under its Early Access to Medicines Scheme (EAMS), is based on thorough evaluation of the benefit or risk balance of the drug and the available data, said the UK regulatory agency.
EAMS has been set up by the MHRA to provide patients with access to medicines that are not yet licenced, but when there is an unmet medical need.
The MHRA decision is expected to support the use of remdesivir in the treatment of patients hospitalised with severe Covid-19 infection who meet additional clinical criteria.
MHRA chief executive June Raine 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.”
EAMS enables use of remdesivir for patients in UK, under high unmet medical need
MHRA said that its scientific opinion does not intend replacing normal licensing procedures for medicines but is aimed at helping prescribers and patients on making a decision on whether to use the medicine prior to its licence approval.
In addition, the regulatory agency is also planning to implement a framework for collecting safety data and manage risks, as part of the scientific opinion.
Through the EAMS, remdesivir can be used in the UK, for patients in high unmet medical need, as determined by a physician. Gilead will provide the drug to the NHS at free of cost throughout the EAMS period.
The MHRA has already approved several ongoing clinical trials to evaluate remdesivir and its possible effects on patients with Covid-19, in the UK. The current opinion will ensure the use of remdesivir to be continued in clinical trials.