Kid'sHealth

U.S. FDA authorizes emergency use of experimental antibody drug Trump took – National

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

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

Read more:
Regeneron: What we know about the experimental coronavirus drug Trump took

The drug is given as a one-time treatment through an IV. The FDA allowed its use in adults and children 12 and over who weigh at least 88 pounds (40 kilograms) and who are at high risk of severe illness from COVID-19 because of age or certain other medical conditions.

Story continues below advertisement

Emergency authorization allows use of the drug to start while studies are continuing to establish safety and effectiveness. Early results suggest the drug may reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression, the FDA said.

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


Click to play video 'Coronavirus: Trump says COVID-19 was ‘blessing from God’, promises to speed approval of medications'







Coronavirus: Trump says COVID-19 was ‘blessing from God’, promises to speed approval of medications


Coronavirus: Trump says COVID-19 was ‘blessing from God’, promises to speed approval of medications – Oct 7, 2020

Initial supplies will likely be vastly outstripped by demand as the U.S. has surged past 10 million reported cases, with the country facing what health experts say will be a dark winter due uncontrolled spread of the virus.

[ Sign up for our Health IQ newsletter for the latest coronavirus updates ]

Antibodies are proteins the body makes 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 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.

Story continues below advertisement

The Regeneron drug is a combo of two antibodies to enhance the chances it will prove effective. Earlier this month, the FDA gave emergency authorization to a single-antibody drug from Eli Lilly that also is still being studied.

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


Click to play video 'Coronavirus: Regeneron co-founder talks about President Trump’s antibody treatment'







Coronavirus: Regeneron co-founder talks about President Trump’s antibody treatment


Coronavirus: Regeneron co-founder talks about President Trump’s antibody treatment – Oct 3, 2020

FDA regulators authorized the Regeneron drug using their emergency powers to quickly speed 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, 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.

Story continues below advertisement

The emergency authorization functions like a temporary approval for the duration of the COVID-19 pandemic. To win full approval, Regeneron will have to submit additional research to fully define the drug’s safety and benefit for patients.

___

AP health writer Matthew Perrone contributed to this report.





© 2020 The Canadian Press

Via Source link

Most Popular

Safety Health News Provides information on HEALTH NEWS, HEALTH CARE, WOMEN’S HEALTH, KID’S HEALTH, MEN’S HEALTH, DIABETES & DEALS NEWS

All About information only. Please consult your Doctor for any illness.

Copyright © 2020 Safety Health News. Powered by Wordpress.

To Top