The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted early access to remdesivir in its medicines scheme for conditions with a high unmet medical need.
Gilead’s remdesivir will now be available to adult and adolescent patients with suspected or confirmed severe Covid-19.
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This decision was based on a scientific view of the clinical evidence of remdesivir against Covid-19; “the MHRA considers the benefit risk balance of remdesivir in the treatment of COVID-19 to be positive for adult and adolescent patients with severe COVID-19. This evaluation takes into account the threat and risk posed by the ongoing COVID-19 pandemic to patients and public health”. However, the scientific opinion document notes that “a risk management plan (RMP) has been developed to ensure that remdesivir is used as safely as possible.”
MHRA chief executive Dr 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.
The UK regulator’s decision to allow unlicensed use of remdesivir follows on from similar moves by the US Food and Drug Administration and the European Medicines Agency earlier this month.
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