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FDA Allows Emergency Use of Received Antibody Drug Trump | National News

FDA Allows Emergency Use of Received Antibody Drug Trump | National News

 


Antibodies are proteins that help the body target and eliminate viruses, but it can take several weeks after an infection occurs before the best antibodies are formed. The drug is a concentrated version of what has proven to be the best way to do this in laboratory and animal experiments, and in theory it helps the body start fighting the virus immediately.

Regeneron drugs are a combination of two antibodies that increase the likelihood of proven efficacy. Earlier this month, the FDA granted an emergency permit for a single-antibody drug from Eli Lilly, which is still under study.

There is no way to know if a regeneron drug has helped Trump recover. He received many treatments and most COVID-19 patients recovered spontaneously.

FDA regulators have used emergency authority to approve Regeneron drugs to expedite the availability of laboratory drugs and other medical products in the event of a public health crisis.

The FDA usually requires “substantial evidence” to show that a drug is safe and effective, usually through the study of one or more large, tightly controlled patients. However, during public health emergencies, authorities can lower those standards and only demand that the potential benefits of treatment outweigh the risks.

Emergency permits act like temporary approvals during the COVID-19 pandemic. To obtain full approval, Regeneron must submit additional studies to fully define the safety and benefits of the drug for the patient.

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What Are The Main Benefits Of Comparing Car Insurance Quotes Online

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