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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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1 posted on 12/23/2022 6:38:16 PM PST by SeekAndFind
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To: gas_dr

ping


2 posted on 12/23/2022 6:41:40 PM PST by Gene Eric (Don't be a statist!)
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To: SeekAndFind

Sure, trust the FDA.


3 posted on 12/23/2022 6:42:17 PM PST by WKUHilltopper
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To: WKUHilltopper

Hospitalized,under care with La Roche’s meds, what great revenue for them.No mention of over 60 use.

Invermecten,less expensive,great results for all,now we can’t have that can we...


4 posted on 12/23/2022 6:49:48 PM PST by skinny old man (Still lurking and posting after all these years(27 yrs ?)(more ?)(seems like more...))
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To: SeekAndFind

Made from humanized mice installed with dead baby body parts. No thanks.


5 posted on 12/23/2022 6:57:45 PM PST by surroundedbyblue (Proud to be an Infidel & a deplorable. )
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To: skinny old man

In severe illness ivermectin is wortthless


6 posted on 12/23/2022 8:09:34 PM PST by gas_dr (Conditions of Socratic debate: Intelligence, Candor, and Good Will)
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To: surroundedbyblue

Completely untrue. Because you choose not To have it should it be necessary doesn’t mean you should deny others based on hyperbolic falsehoods


7 posted on 12/23/2022 8:11:00 PM PST by gas_dr (Conditions of Socratic debate: Intelligence, Candor, and Good Will)
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To: Gene Eric

Thanks for the ping. This is good news


8 posted on 12/23/2022 8:11:29 PM PST by gas_dr (Conditions of Socratic debate: Intelligence, Candor, and Good Will)
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To: SeekAndFind

Tocilizumab is an IL-6 inhibitor and we’ve been using it (or baricitinib) since the Fall of 2020.


9 posted on 12/23/2022 8:13:36 PM PST by Jim Noble (I feel my heart beat faster any place in the neighborhood of the Astor)
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To: skinny old man

“No mention of over 60 use.”

In September 2021, Hubby and I got the minimal treatment and we’re in our 70s.

“Invermecten,bless expensive,great results for all,”

Ivermectin and monoclonal don’t do the same thing so it doesn’t have to be either/or.

We both had monoclonal. Then I took IVM, too. (Hubby didn’t take IVM. My recovery was faster than his, FWIW.)


10 posted on 12/23/2022 8:17:41 PM PST by MayflowerMadam
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To: skinny old man; gas_dr

“Invermecten,less expensive,great results for all,now we can’t have that can we...’

I sure can’t see how it has done much for me in the last week. In fact, just like the last time I had COVID six months ago, I seemed to get sicker AFTER taking the ivermectin! Not saying the deterioration really was due to the ivermectin, but it’s hard to see how it helped much! True, I’m not in the hospital, but few are nowadays without substantial comorbidities.


11 posted on 12/23/2022 8:21:42 PM PST by steve86 (Prophecies of Maelmhaedhoc O'Morgair (Latin form: Malachy))
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To: SeekAndFind

Now that no one needs it any longer


12 posted on 12/23/2022 8:33:13 PM PST by TheElectionWasStolen
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To: SeekAndFind

I have lost complete trust in all of them. I’ll never get a shot for anything ever again


13 posted on 12/23/2022 8:37:12 PM PST by roving ( Pronouns- libs/suk)
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To: SeekAndFind

This is another example of FDA mission creep.

The FDA does not “approve” nor to they “prohibit” the use of licensed drugs for any indication a licensed physician believes they might be useful.

Tocilizumab was licensed in 2003 for treatment of certain inflammatory diseases such as rheumatoid arthritis.

It works by inhibiting interleukin 6 (IL-6).

As soon as the role of IL-6 in fatal COVID was understood, certainly by August 2020, anyone with a license could prescribe it for a COVID patient. FDA PERMISSION IS NOT NECESSARY FOR ANY USE OF ANY LICENSED DRUG, much as FDA would like that to be the case.


14 posted on 12/23/2022 8:45:03 PM PST by Jim Noble (I feel my heart beat faster any place in the neighborhood of the Astor)
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To: Taxman

Ping


15 posted on 12/23/2022 9:00:23 PM PST by Taxman (SAVE AMERICA! VOTE REPUBLICAN IN 2023 AND 2024!)
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To: gas_dr

Hyperbolic falsehoods? Prove me wrong.


16 posted on 12/23/2022 11:24:00 PM PST by surroundedbyblue (Proud to be an Infidel & a deplorable. )
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To: surroundedbyblue; gas_dr

“Made from humanized mice installed with dead baby body parts. No thanks.”

This sounds like the BS scare story that the kooks were pushing about the HEK-293 cell line that was used for testing Covid vaccines. It’s an immortal cell line that originated from an embryo kidney cell in the 1970s and it’s been used for testing drugs ever since. The kooks love to claim that it’s in the drugs themselves when it never has been, it’s a test bed for drugs.

“Humanized mice” is probably supposed to be “humanized antibody” since tocilizumab is a “humanized antihuman IL-6 receptor antibody”. There’s also monoclonals known as “chimeric antibodies” that have an animal origin but tocilizumab isn’t one of those.

Humanized mice do exist but like the immortal embryo cell line they are for testing.


17 posted on 12/24/2022 12:36:05 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: gas_dr

Welcome back! We’ve missed you!


18 posted on 12/24/2022 1:08:11 AM PST by vivenne
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To: Pelham

The involvement of HEK-293 in testing a drug disqualifies that drug for use by an ethical Christian. We’re kooks.


19 posted on 12/24/2022 1:13:59 AM PST by steve86 (Prophecies of Maelmhaedhoc O'Morgair (Latin form: Malachy))
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To: Jim Noble; steve86

When the wife brought COVID home last Dec, I did Ivermectin and got her in for the tocilizumab treatment. We had already started on 5,000ui Vit D, 25mg zinc, doxycycline and multivitamin heavy on Vit C.

Both of us made it through just fine and I’d say fairly equally. Gotta have the Vit D and zinc along with ivermectin.


20 posted on 12/24/2022 5:28:35 AM PST by Pollard ( >>> The Great Reset is already underway! <<<)
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