RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Regulatory Focus™ > News Articles > 2020 > 5 > UK grants early access to remdesivir for COVID-19

UK grants early access to remdesivir for COVID-19

Posted 26 May 2020 | By Michael Mezher 

UK grants early access to remdesivir for COVID-19

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday issued a positive early access to medicines scheme (EAMS) opinion for Gilead Sciences’ remdesivir to provide the drug via the National Health Service to certain hospitalized patients with severe cases of coronavirus disease (COVID-19).
 
“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,” the UK’s Department of Health and Social Care said.
 
First launched in 2014, EAMS is intended to speed the availability of potentially lifesaving medicines for patients with severe or life-threatening conditions before formal marketing authorization is granted.
 
The move follows the US Food and Drug Administration’s move to grant emergency authorization for remdesivir and the start of the European Medicines Agency’s rolling review of the drug earlier this month.
 
MHRA says the decision was made following a “rigorous evaluation of the benefit/risk balance of the medicine,” based on available data.
 
“We are committed to ensuring that patients can have fast access to promising new treatments for COVID-19,” said MHRA Chief Executive June Raine.
 
Under the treatment protocol specified in the EAMS opinion, remdesivir may be used to treat patients ages 12 and older who weigh at least 40kg. Patients must be hospitalized 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) to receive remdesivir via EAMS.
 
MHRA, EAMS scientific opinion

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe

Regulatory Focus™ is doing essential, non-biased journalism during this unprecedented time. We appreciate your support as we bring you the news and intelligence you need to make an impact on global healthcare.

Regulatory Focus™ provides the intelligence you need to impact global healthcare during this crisis. Thank you for your support.