Momentum continues to be gained in the fight against COVID-19 as the Food and Drug Administration (FDA) in the United States have approved of the emergency use of a second antibody drug to strengthen the immune system to fight the virus.
The antibody-drug which is produced by Regeneron Pharmaceuticals Inc. is administered to try to prevent hospitalization and worsening disease from developing in patients with mild-to-moderate symptoms of COVID-19.
According to CBN News, US President, Donald Trump, received the antibody-drug, among others, when he was sick of COVID-19 last month.
The FDA allowed the use of the drug in adults and children of 12 years and above who weigh at least 88 pounds (40 kilograms) and who are at high risk of severe illness from COVID-19.
The drug is given as a one-time treatment through intravenous therapy.
Early results suggest the drug may reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression.
The Regeneron drug is a combo of two antibodies to enhance the chances it will prove effective.
Antibodies are proteins the body makes to target and help eliminate viruses.
The drugs are concentrated versions of ones that proved best able to do this in lab and animal tests, and in theory, help the body start to fight the virus right away.
Regeneron said that initial doses will be made available to roughly 300,000 patients through a federal government allocation program, such that the patients will not be charged for the drug but may have to pay part of the cost of giving the intravenous.
Initial supplies will likely be vastly outstripped by demand as the U.S. has surged past 12 million reported cases, with the country facing what health experts say will be a dark winter due to the uncontrolled spread of the virus.
There are also persons with arguments that there is no way to know whether the Regeneron drug helped Trump recover noting that the US President received a host of treatments and that most COVID-19 patients recover on their own.
Suffice it to note, however, that FDA regulators authorised the Regeneron drug, using their emergency powers, to quickly speed up the availability of experimental drugs and other medical products during public health crises.
The emergency authorisation allows the use of the drug to start while studies are continuing to establish safety and effectiveness.
In normal times the FDA requires “substantial evidence” to show that a drug is safe and effective, usually through one or more large, rigorously controlled patient studies, but during public health emergencies, the agency can lower those standards and require only that an experimental treatment’s potential benefits outweigh its risks.
The emergency authorization functions like a temporary approval for the duration of the COVID-19 pandemic.
To win full approval, Regeneron will still have to submit additional research to fully define the drug’s safety and benefit for patients.
COVID-19: FDA approves emergency use of drug Trump received