An experimental drug used by Donald Trump when he had COVID-19 has received emergency approval by US health authorities.
The antibody drug developed by Regeneron Pharmaceuticals is administered in a single intravenous dose, and can be now used in coronavirus patients in the US even though studies examining how safe and effective it is are still ongoing.
Regeneron hopes the drug will be able to prevent COVID-19 patients with mild to moderate symptoms being hospitalised by boosting their immune system response.
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The US Food and Drug Administration (FDA) is permitting the drug to be used to treat adults and children aged 12 and over, as long as they weigh at least 88 pounds (40kg), and are at high risk of severe illness from COVID-19.
According to Regeneron, initial doses will be available for roughly 300,000 patients through a federal government allocation program. Although those patients won’t be charged for the drug, they may have to pay part of the cost of giving the IV.
Demand for the drug is expected to vastly outweigh the initial supplies, with the US surging past 12 million reported cases in recent days.
More than 100,000 new cases have been reported every day since 4 November and health experts warn the country faces a challenging winter due to the uncontrolled spread of the virus.
It is impossible to know whether the Regeneron drug helped Mr Trump recover from COVID-19 as it was one treatment among a host that he received, and most patients recover on their own.
The FDA used its emergency powers to authorise the drug as the total number of coronavirus-related deaths in the US passed 256,000 amid a lack of treatments for the novel disease.
During non-emergency times the FDA required “substantial evidence” before approving a drug as safe and effective, but these standards have been lowered during the public health emergency.
Now the only requirement is that the experimental treatment’s potential benefits outweigh its risks.
As an emergency authorisation, the approval will only last for the duration of the COVID-19 pandemic, and afterwards Regeneron will need to submit additional research to define how safe and effective it is.
The White House described the FDA’s decision as a victory for Mr Trump’s efforts “to deliver cutting-edge treatments with highly promising results to protect the health and safety of the most vulnerable Americans”.