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FDA Approves Monoclonal Antibody To Treat COVID-19 For First Time
Epoch Times ^ | 12/23/2022 | Mimi Nguyen Ly

Posted on 12/23/2022 6:38:16 PM PST by SeekAndFind

The U.S. Food and Drug Administration (FDA) has, for the first time, approved a monoclonal antibody to treat COVID-19 in hospitalized patients.

Healthcare company Roche’s Actemra (tocilizumab) intravenous (IV) was approved by the FDA to treat severe COVID-19 in adults, the company announced on Wednesday.

Specifically, the drug is approved in cases where the patient is hospitalized and is receiving systemic corticosteroids, as well as requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.

It is the first FDA-approved monoclonal antibody to treat COVID-19, the company stated.

Monoclonal antibodies are laboratory-created proteins that mimic natural antibodies the body produces to fight off harmful pathogens, such as the SARS-CoV-2 virus that causes COVID-19.

Actemra does not directly target SARS-CoV-2 but addresses the inflammation that occurs from COVID-19 infection. The monoclonal antibody reduces inflammation by blocking the interleukin-6 receptor.

The drug is recommended to be administered as a single 60-minute IV infusion.

According to Roche, more than one million hospitalized COVID-19 patients have been treated with Actemra worldwide since the start of the pandemic.

The drug was previously FDA-authorized for emergency use in hospitalized adults and pediatric COVID-19 patients (above 2 years of age) back in June 2021.

Right now, the FDA has not approved Actemra to treat hospitalized patients aged 2 to under 18, but the Emergency Use Authorization (EUA) still applies.

Actemra is not authorized or approved for the treatment of outpatients with COVID-19.

According to Roche, Actemra is approved for use in more than 30 countries for patients hospitalized with severe COVID-19. This includes the European Union, Japan, the United Kingdom, New Zealand, Russia, and Brazil. It is also provisionally approved in Australia, and authorized for emergency use in Ghana, Mexico, and Korea for certain patients hospitalized with severe or critical COVID-19.

The drug has also been recommended and prequalified by the World Health Organization (WHO).

In the United States, Actemra is the seventh FDA-approved indication since it was launched in 2010. It has been approved for use against other inflammatory diseases, including rheumatoid arthritis.


TOPICS: Health/Medicine; Science; Society
KEYWORDS: covid; fda; monoclonals
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To: SeekAndFind

Its not a monoclonal antibody.

Its an interleukin 6 antagonist used to treat RA.

Talk about inaccurate reporting!!!


21 posted on 12/24/2022 5:49:34 AM PST by MarMema (Biden = Americans Last)
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To: gas_dr; Jim Noble

Its not a monoclonal antibody!!! Hello.

Its an interleukin 6 antagonist.
A glorified inhibitor of inflammation, it does nothing specifically for covid.

This is stupid news and very inaccurate reporting.


22 posted on 12/24/2022 5:52:49 AM PST by MarMema (Biden = Americans Last)
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To: Pelham

Its not an antibody!!!!!

Its an antagonist. A chemical.

Where are other science freepers?


23 posted on 12/24/2022 5:55:16 AM PST by MarMema (Biden = Americans Last)
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To: MarMema

You are correct I read the headline and the ping. Tolci was ok but Not great. Monoclonal specific to the disease remain the best


24 posted on 12/24/2022 7:35:03 AM PST by gas_dr (Conditions of Socratic debate: Intelligence, Candor, and Good Will)
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To: MarMema

It is a monoclonal antibody but against the IL6 receptors not against covid specifically.


25 posted on 12/24/2022 7:38:09 AM PST by Mom MD ( )
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To: gas_dr

“ In severe illness ivermectin is wortthless”

And the dirty little secret is that people like you, who call ivermectin worthless, were underdosing it. How many patients have you poisoned with remdesivir? How many patients have you denied informed consent to by pushing toxic poisons like remdesivir & “vaccines”? And have you advised patients who are pro life about the diabolical origins of the vaccines and monoclonal? Their link to abortions?


26 posted on 12/24/2022 9:32:42 AM PST by surroundedbyblue (Proud to be an Infidel & a deplorable. )
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To: gas_dr

“In severe illness ivermectin is wortthless”

The gasbag_dr is back.

The whole idea behind Ivermectin is EARLY treatment. If you take it early you don’t get SEVERE illness.

I have Ivermectin on standby. At the first sign of anything that could be COVID I take it.

Of course thanks to our EVIL government, I had to get it from INDIA!


27 posted on 12/24/2022 9:32:42 AM PST by faucetman (Just the facts, ma'am, Just the facts )
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To: gas_dr

The processes used to humanize the mice used for the production of monoclonals is clearly detailed for all to see. Only one who chooses to be blind refuses to see the clear and proximal link to abortion


28 posted on 12/24/2022 9:33:52 AM PST by surroundedbyblue (Proud to be an Infidel & a deplorable. )
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To: SeekAndFind

I read somewhere just recently that monoclonal antibodies were phased out, didn’t work.


29 posted on 12/24/2022 9:34:06 AM PST by faucetman (Just the facts, ma'am, Just the facts )
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To: Pelham

Firstly, we aren’t talking about HEK293 here. The humanized mice require recent abortions to harvest bone marrow and thymus from babies.

Second, even if the HEK293 fetal cell line was the only involvement of abortion in the production of these drugs, no pro life Christian can in good conscience take them. If that makes us kooks then I propose that YOU are the kook. Who in their right mind thinks these drugs, whose existence rely solely on murdered children, are acceptable?


30 posted on 12/24/2022 9:37:07 AM PST by surroundedbyblue (Proud to be an Infidel & a deplorable. )
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To: faucetman

They worked, that’s why they were phased out


31 posted on 12/24/2022 9:37:24 AM PST by 38special (I should've said something earlier)
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To: steve86

Good luck with that theory. HEK has been used to test common OTC meds like aspirin and ibuprofen.


32 posted on 12/24/2022 9:38:52 AM PST by Pelham (World War III will be fought with nuclear weapons. World War IV will be fought with rocks & sticks.)
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To: MarMema

It is a monoclonal antibody against the IL-6 receptor.

Any drug ending in -mab is a monoclonal antibody and there are hundreds either on the market or in the Big Pharma pipeline undergoing clinical trials


33 posted on 12/24/2022 9:40:55 AM PST by surroundedbyblue (Proud to be an Infidel & a deplorable. )
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To: Pelham

HEK was used to test common OTC drugs for ridiculous reasons, but it has not been used in the creation of all drugs.

For example, older medications like aspirin and metoprolol do not owe their existence to HEK293. Big difference.


34 posted on 12/24/2022 9:42:41 AM PST by surroundedbyblue (Proud to be an Infidel & a deplorable. )
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To: surroundedbyblue

Please provide a link to the crackpot website you’re using for your expertise on this subject.


35 posted on 12/24/2022 9:48:30 AM PST by Pelham (World War III will be fought with nuclear weapons. World War IV will be fought with rocks & sticks.)
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To: Pelham

I don’t need to justify myself to disgusting people like you who profit off the backs of unborn children and gaslight those of us who say it’s wrong. If you’re moral compass is that broken than maybe you should spend less time on FR and more time praying.


36 posted on 12/24/2022 9:55:19 AM PST by surroundedbyblue (Proud to be an Infidel & a deplorable. )
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To: Pelham

https://cogforlife.org/2021/05/12/lets-get-a-few-things-cleared-up-testing-cell-lines-and-fetal-tissue/

https://takingrecourse.com/dr-paul-casey-md-the-everything-was-tested-on-hek-lie/

These two articles link many sources that will satisfy your question. If you continue to insist on your initial premise, then you are choosing to remain blind.


37 posted on 12/24/2022 9:59:11 AM PST by surroundedbyblue (Proud to be an Infidel & a deplorable. )
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To: surroundedbyblue; Pelham

Same article at different site. Lots of citations throughout

https://catholicfamilynews.com/blog/2021/12/09/the-everything-was-tested-on-hek-lie/


38 posted on 12/24/2022 10:01:34 AM PST by surroundedbyblue (Proud to be an Infidel & a deplorable. )
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To: surroundedbyblue

No drugs “owe their existence” to HEK. It’s a test bed for checking safety including for the OTC painkillers that you’re trying to exempt from your guilt by association game.


39 posted on 12/24/2022 10:07:11 AM PST by Pelham (World War III will be fought with nuclear weapons. World War IV will be fought with rocks & sticks.)
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To: Pelham

Hahahahaha ok. Yeah I see you didn’t bother to read anything I sent nor do you know what you’re talking about. Uninformed opinions seem to abound on this forum and it’s really sad. It used to be a great place full of critical & analytical THINKERS. And people who were genuinely pro life


40 posted on 12/24/2022 10:09:53 AM PST by surroundedbyblue (Proud to be an Infidel & a deplorable. )
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