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UK clears NHS use of Gilead’s remdesivir for COVID-19 patients

MHRA approved the drug under the Early Access to Medicines Scheme


The UK medicines regulator has cleared early access to Gilead Sciences’ coronavirus drug remdesivir for people hospitalised with severe coronavirus infection, although supplies will initially be limited.

The Medicines and Healthcare products Regulatory Agency (MHRA) approved the drug under the Early Access to Medicines Scheme (EAMS), used to hasten access to unlicensed drugs for life-threatening or seriously debilitating conditions.

The US and Japan have also approved emergency use of remdesivir, while the European Commission has issued recommendations for compassionate use and started a rolling review of its use in coronavirus patients.

The government said remdesivir will be available to “selected” COVID-19 patients, with treatment prioritised for patients who have the greatest likelihood of deriving a benefit from the antiviral drug.

Just-published data from the 1,063-patient ACTT-1 trial of remdesivir has shown that a ten-day course of the drug can cut four days off the time that people with COVID-19 spend in hospital – from 15 to 11 – but the results also suggest it doesn’t help more severe cases requiring mechanical ventilation.

The finding suggests that remdesivir should be reserved for use in patients who aren’t critically ill with COVID-19 while it is in short supply.

Additional trials of the drug are also underway around the world, including in the UK where it is being tested in the World Health Organization’s multi-drug SOLIDARITY trial, one of the largest with an enrolment of more than 3,500 subjects.

A trial in China that was terminated early found little sign of benefit from the drug, but that was in a very low number of patients.

Gilead is also running its own phase 3 trials, with new data due to be reported at the end of this month. An earlier phase 3 readout showed that a five-day course seemed to be as effective as the ten-day regimen in treating infections with SARS-CoV-2, the virus that causes COVID-19.

The MHRA approval comes as coronavirus death registrations in the UK have dipped to their lowest level since early April, with reductions in both the general population and care home settings.

Health Secretary Matt Hancock tweeted that the EAMS approval of remdesivir is “probably the biggest step taken since the coronavirus crisis began”.

The MHRA said the decision was made following a “rigorous evaluation of the benefit/risk balance of the medicine”, based on available data.

According to the EAMS protocol, remdesivir can be used to treat patients ages 12 and older who weigh at least 40kg. They must be hospitalised with suspected or confirmed SARS-CoV-2 infection and have diminished oxygen saturation on room air or require supplemental oxygen, ventilation or extracorporeal membrane oxygenation (ECMO).

Article by
Phil Taylor

27th May 2020

From: Research, Regulatory, Healthcare



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