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- Innovative medicine with promising results in clinical trials to be made available to selected
- Government working in collaboration with manufacturer
- Large international study including
Selected
Thanks to the joined-up efforts of the
The drug is currently undergoing clinical trials around the world, including in the
The Early Access to Medicines Scheme (EAMS) and scientific opinion from MHRA supports remdesivir to be used by selected
Minister for Innovation
This shows fantastic progress. As we navigate this unprecedented period, we must be on the front foot of the latest medical advancements, while always ensuring patient safety remains a top priority
The latest, expert scientific advice is at the heart of every decision we make, and we will continue to monitor remdesivir's success in clinical trials across the country to ensure the best results for
Allocation of the drug will be based on expert clinical advice and will take into consideration the situation where it is most likely to provide the greatest benefit.
The
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
Background information
- Similar arrangements have already been made with other countries, including an emergency authorisation from the FDA in the US and MHLW/PMDA in
- EAMS aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation, when there is a clear medical need.
- Under the scheme, MHRA will give a scientific opinion on 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 clinicians and patients to make a decision on whether to use the medicine before its licence is approved.
- MHRA and the
- The scientific opinion describes the risks and benefits of the medicine based on data gathered from the patients who will benefit from the medicine. The opinion supports the prescriber and patient to make a decision on whether to use the medicine before its licence is approved.
- Find out more about the
- The drug will be used in adults and adolescents hospitalised with severe COVID-19 infection who meet clinical criteria suggesting they have the greatest likelihood of benefiting.
- The arrangements for allocation across the
- Supply of the drug through this arrangement will be separate to the clinical trials currently occurring in the
.
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