Selected NHS coronavirus patients will soon be able to access a
treatment to speed up their recovery.
Thanks to the joined-up efforts of the UK Government, the
Devolved Administrations, pharmaceutical company Gilead Sciences,
the NHS, and the MHRA, the anti-viral drug remdesivir will be
made available to patients meeting certain clinical criteria to
support their recovery in hospital.
The drug is currently undergoing clinical trials around the
world, including in the UK, with early data showing it can
shorten the time to recovery by about 4 days.
The Early Access to Medicines Scheme (EAMS) and scientific
opinion from the Medicines and Healthcare products Regulatory
Agency (MHRA) supports remdesivir to be used by selected NHS
patients. For the time being and due to limited supplies,
treatment will be prioritised for patients who have the greatest
likelihood of deriving the most benefit.
Minister for Innovation
said:
‘“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 UK patients.”
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 UK Government continues to work closely with its partners
across the Devolved Administrations, the health system and
industry to ensure UK patients have the greatest possible chance
of getting the latest, ground-breaking treatments as quickly as
possible.
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.”
Hilary Hutton-Squire, Vice President and General Manager, Gilead
Sciences UK and Ireland said:
“We are delighted that the MHRA and the Commission on Human
Medicines (CHM) have decided to issue remdesivir a positive
Scientific Opinion within the Early Access to Medicines Scheme
(EAMS).
‘’This decision reflects Gilead’s commitment to rapidly respond
to the COVID-19 pandemic.
‘’Treatment options in response to this global public health
emergency are urgently needed and we are grateful to the UK
government and the MHRA for their continued support and
collaboration to make this medicine available to those patients
who are most likely to benefit from it. We will continue to work
closely with the government to supply remdesivir across the UK.”
Notes to Editors:
· Similar arrangements have already been made with other
countries, including an emergency authorisation from the FDA in
the US and MHLW/PMDA in Japan.
· The Early Access to Medicines Scheme (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, the 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.
· The MHRA and the Commission on Human Medicines (CHM) considered
the emerging results of an Active COVID-19 Treatment Trial (ACTT)
study, and other studies conducted by Gilead. The data was
sufficient to meet the criteria for an EAMS scientific opinion,
and the benefits were determined to outweigh the risks.
· 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 NIHR’s national process to prioritise
COVID-19 research. Details on the process and the new single
point of entry for prioritising COVID-19 studies can be found
here.
· 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 benefitting.
· The arrangements for allocation across the NHS is in place to
distribute the medicine. NHSE will manage this allocation in
collaboration with all four nations.
Supply of the drug through this arrangement will be separate to
the clinical trials currently occurring in the UK and around the
world.
