As of this morning – Monday May 4 – the current recorded case count for COVID-19 (coronavirus) in the UK has hit 186,599 with 28,446 deaths.
The US Food and Drug Administration has issued an emergency use authorisation for Gilead’s investigational antiviral remdesivir for the treatment of COVID-19 in adults and children hospitalised with severe disease.
The authorisation is temporary and does not take the place of the formal new drug application submission, review and approval process.
The move follows data from a clinical trial – sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) – showing that the drug accelerated recovery time in hospitalised patients.
Preliminary results indicate that patients who received remdesivir had a 31% faster time to recovery than those who received placebo. Specifically, the median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received placebo. Results also suggested a survival benefit, with a mortality rate of 8.0% for the group receiving remdesivir versus 11.6% for the placebo group.
While data remains limited, it is thought that possible side effects of remdesivir include: increased levels of liver enzymes, which may be a sign of inflammation or damage to cells in the liver; and infusion-related reactions, which may include low blood pressure, nausea, vomiting, sweating, and shivering.
The emergency use authorisation allows for remdesivir to be distributed in the US and administered intravenously by healthcare providers to treat suspected or laboratory-confirmed COVID-19 in hospitalised patients with severe disease, that is patients who have low blood oxygen levels or need oxygen therapy or more intensive breathing support such as a mechanical ventilator.
It only valid until the circumstances justifying its emergency use change and can be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.
“This EUA opens the way for us to provide emergency use of remdesivir to more patients with severe symptoms of COVID-19,” said Daniel O’Day, chairman and chief executive of Gilead Sciences.
“We will continue to work with partners across the globe to increase our supply of remdesivir while advancing our ongoing clinical trials to supplement our understanding of the drug’s profile.”
WASH YOUR HANDS:
Regularly and thoroughly clean your hands with an alcohol-based hand rub or wash them with soap and water.
MAINTAIN SOCIAL DISTANCING:
Maintain at least two metres (six feet) distance between yourself and anyone who is coughing or sneezing.
STAY AT HOME:
Only go outside for food, health reasons or work (but only if you cannot work from home).
