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FDA allows emergency use of Regeneron’s antibody drug, treatment Trump received when he became ill with COVID



U.S. health officials on Saturday agreed to allow emergency use of another antibody drug to help the immune system fight COVID-19, an experimental drug that President Donald Trump was given when he fell ill last month.

The Food and Drug Administration approved the use of the drug Regeneron Pharmaceuticals Inc. to try to prevent hospitalization and exacerbation of the disease from developing in patients with mild to moderate symptoms.

The drug is given as a single treatment through an IV. The FDA approved its use in adults and children 12 years of age and older who weigh at least 40 kg (40 kg) and who are at high risk for serious illness due to COVID-19 due to age or certain other medical conditions.

Emergency authorization allows the use of the drug to start while studies continue to determine safety and effectiveness. Early results suggest the drug may reduce COVID-1

9-related hospitalization or emergency visits in patients at high risk for disease progression, the FDA said.

MORE: What does emergency use of a COVID-19 vaccine mean?

Regeneron said initial doses will be made available for approx. 300,000 patients through a federal allocation program. These patients will not be charged anything for the drug, but may have to pay part of the cost of giving IV.

Initial supplies are likely to far exceed demand as the U.S. has increased over 12 million reported cases in which the country faces what health experts say will be a dark winter due to uncontrolled spread of the virus.

Antibodies are proteins that the body produces to target and help eliminate viruses, but it can take weeks for the best ones to form after an infection occurs. The drugs are concentrated versions of those that proved to be best able to do this in laboratory and animal experiments and in theory help the body to start fighting the virus immediately.

The regeneron drug is a combination of two antibodies to increase the chances that it will prove effective. Earlier this month, the FDA granted emergency approval for a single antibody drug from Eli Lilly, which is also still under investigation.

There is no way to know if the Regeneron drug helped Trump recover; he received a host of treatments and most COVID-19 patients recovered on their own.

FDA regulators approved the Regeneron drug using their emergency powers to rapidly accelerate the availability of experimental drugs and other medical products during public health crises.

In normal times, the FDA requires “substantial evidence” to show that a drug is safe and effective, usually through one or more large, strictly controlled patient studies. However, in public health emergencies, the Agency may lower these standards and only require that the potential benefits of an experimental treatment outweigh its risks.

The emergency clearance acts as a temporary clearance throughout the COVID-19 pandemic. To gain full approval, Regeneron will need to submit further research to fully define the safety and benefit of the drug for patients.

The White House ran the decision as a victory for Trump’s efforts “to deliver groundbreaking treatments with very promising results to protect the health and safety of the most vulnerable Americans,” according to a statement from spokesman Michael Bars.

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AP health author Matthew Perrone contributed to this report.

Copyright © 2020 by the Associated Press. All rights reserved.




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