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Regeneron’s COVID-19 Antibody Treatment Authorized for Injection
Epoch Times ^
| 06/05/2021
| Mimi Nguyen Ly
Posted on 06/05/2021 8:02:25 PM PDT by SeekAndFind
Regeneron announced on Friday that the Food and Drug Administration (FDA) is allowing a lower dose of its CCP virus treatment for injection.
The approval comes as an update to the FDA’s emergency use authorization (EUA) for the company’s antibody cocktail to treat COVID-19, the disease caused by the CCP (Chinese Communist Party) virus. The treatment has been available under the EUA since last November for those recently diagnosed with COVID-19.
The FDA had in November authorized a 2,400 mg dose of the antibody cocktail REGEN-COV—a combination of the monoclonal antibodies casirivimab and imdevimab—to be administered as a single dose directly injected to a vein for non-hospitalized COVID-19 patients.
As part of the updated EUA, REGEN-COV is approved for injection “when IV infusion is not feasible and would lead to a delay in treatment.”
The new dose authorized for both injection and IV infusion would be 1,200 mg (600 mg casirivimab and 600 mg imdevimab)—half that of the originally authorized dose. The move means that more doses will now be available for patients under the company’s contract with the U.S. government.
Regeneron recently announced that its Phase 3 trial showed that its drug reduced the risk of hospitalization or death by 70 percent in high-risk patients with mild to moderate symptoms of COVID-19. The trial also showed that the treatment effect was consistent between 1,200 mg and 2,400 mg doses.
The updated authorization (pdf) allows the drug to be combined into a single vial for injection, although it can still be administered via separate individual vials.
“Despite increased use of vaccines, thousands of patients are still becoming infected in the U.S. every day, with many at high risk of serious complications from COVID-19,” George Yancopoulos, the president and chief scientific officer at Regeneron, said in a statement.
(Excerpt) Read more at theepochtimes.com ...
TOPICS: Health/Medicine; Science; Society
KEYWORDS: allocetra; anthonyfauci; antibody; authorization; chinavirus; chinavirustreatment; covid19; covidstooges; enlevix; monoclonalantibodies; monoclonalantibody; regeneron
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To: Mom MD
Good point. We can take the 36,000 extra pay we received per case that lead to death and go to southern Italy for the summer. Rub elbows with the other global Elitists and rich and famous.
See you in Sardinia. I’ll send the private jet.
21
posted on
06/05/2021 9:07:33 PM PDT
by
gas_dr
(Conditions of Socratic debate: Intelligence, Candor, and Good Will. )
To: Mom MD
Oh and I see the Quoctors have arrived.
22
posted on
06/05/2021 9:09:08 PM PDT
by
gas_dr
(Conditions of Socratic debate: Intelligence, Candor, and Good Will. )
To: SeekAndFind; gas_dr
Will Eli Lilly be able to follow suit with their MAB cocktail (i.e., reduce dosage by 50% and administer via injection)? Their EUA states:
Under this EUA, bamlanivimab and etesevimab must be administered together after dilution by intravenous (IV) infusion only. Bamlanivimab and etesevimab may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary. The authorized dosage is 700 mg bamlanivimab and 1,400 mg of etesevimab administered together as a single intravenous (IV) infusion as soon as possible after positive viral test for SARS-CoV-2 and within ten days of symptom onset.
23
posted on
06/05/2021 9:19:39 PM PDT
by
ProtectOurFreedom
(“Access to the free and #OpenInternet is an essential human right in modern society.” -- Twitter)
To: SeekAndFind
It was a game changer. Symptoms better for mist people within a day or so.
To: arkfreepdom
The best therapy so far. The other game changer was adding decadron in some cases.
25
posted on
06/05/2021 9:31:52 PM PDT
by
Mom MD
( )
To: Mom MD
Yes. I didn’t admit one person after monoclonal antibodies. I know it’s not 100% but it was for me.
To: arkfreepdom
I don’t believe I saw anyone in hospital that had had monoclonal antibodies. i also know anecdotally several people that were headed for hospitalization that were turned around with Regeneron and did not ultimately need admission
27
posted on
06/05/2021 9:44:05 PM PDT
by
Mom MD
( )
To: arkfreepdom
I got the Regeneron about 6 days after I came down with the ‘rona. The reason I got it was due to diabetes.
Got the treatment in the afternoon, had a slight allergic reaction in the evening, but starting the next day I felt MUCH better.
Of the people in my household, I was the first one that recovered. I thank the Regeneron fore that.
28
posted on
06/05/2021 9:51:27 PM PDT
by
hoagy62
(DTCM&OTTH)
To: SeekAndFind
Advice. Don’t EVER LET THEM INJECT ANYTHING INTO YOU!!!
Taking blood OUT is fine.
No shots Ever !
29
posted on
06/05/2021 10:14:23 PM PDT
by
Truthoverpower
(Arizona !!!! Now the TRUMP TRAIN is getting back on TRACK ! TRUTH! FREEDOM ! LIBERTY! )
To: EinNYC
30
posted on
06/05/2021 10:18:57 PM PDT
by
Truthoverpower
(Arizona !!!! Now the TRUMP TRAIN is getting back on TRACK ! TRUTH! FREEDOM ! LIBERTY! )
To: hoagy62
Thanks for your first-hand report.
31
posted on
06/05/2021 10:24:28 PM PDT
by
mrsmith
(US MEDIA: " Every 'White' cop is a criminal! And all the 'non-white' criminals saints!")
To: hoagy62
Thankful to hear you’re feeling better!
President Trump called his monoclonal antibody therapy a miracle. Seems to work extremely well for most. Glad you listened to medical professionals and not anyone playing Internet doctor.
32
posted on
06/06/2021 12:10:33 AM PDT
by
2aProtectsTheRest
(The media is banging the fear drum enough. Don't help them do it.)
To: gas_dr
Your precious vaccine has killed thousands. It also isn’t a cure
33
posted on
06/06/2021 1:12:38 AM PDT
by
roving
To: Truthoverpower
Yeah, those Polio and Measles vacs were eeevil, along with the ones for Tetanus and Diptheria
To: gas_dr
Gas_dr,
What do you hear about Enlevix and their drug Allocetra?
I've heard the Israeli's have allowed it for Sepsis and Covi on an emergency basis and it worked. I haven't been able to 2nd source it, one news blurb and that's it.
Go here: https://enlivex.com/
35
posted on
06/06/2021 2:42:04 AM PDT
by
taildragger
("Do you hear the people Singing? Singing the Songs of Angry Men!")
To: roving
I’m so glad you said that. What is your data source? Suspect VARERS which is what the Quoctors are spreading.
So let’s your “thousands”. Specifically five thousand. Using that number and averaging to daily deaths we find 22/ day from the vaccine. (The number from VAERS is of course overinflated because it does not have a time frame and it let the database only shows events but not events CAUSED by the vaccine). There are approximately 110 deaths a day from automobile transportation. Your chances of dying getting into your car are 5x greater than getting a vaccine. Even using your own numbers. Can you possibly state now that you will not get in your precious car? You risk other people’s lives by doing so.
Of course there have also been over 600,000 deaths from CoVi-2 thus far with a strong correlation of inverse relationship to new cases as compared to vaccination. And see Israel for a real world study.
The bottom line is you spew attacks and no data. And you will no doubt be like the rest of the Quoctors now. You have been directly confronted with data and the assumption is we use YOUR number regarding deaths. And it still shows despite your number being inflated the safety and efficacy of the vaccination.
Have a good day.
36
posted on
06/06/2021 4:29:53 AM PDT
by
gas_dr
(Conditions of Socratic debate: Intelligence, Candor, and Good Will. )
To: mrsmith
Seems like the mabs are the latest “panacea” with only 12 times the potential bad side effects of their predecessors...
37
posted on
06/06/2021 4:44:13 AM PDT
by
trebb
(Fight like your life and future depends on it - because they do.)
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