Regeneron’s COVID-19 Antibody Treatment Authorized for Injection

Epoch Times ^ | 06/05/2021 | Mimi Nguyen Ly

[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.

[E. Pluribus Unum]

More violations of the Nuremberg code.

[Jane Long]

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.

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Wow....almost the higher efficacy rate as Ivermectin!

[mrsmith]

Other Mabs are not effective against variants- but Regeneron is.

[SeekAndFind]

RE: Other Mabs are not effective against variants- but Regeneron is.

If it is, then it has to be given widely on an outpatient basis. Unfortunately it isn’t convenient to do that, it has to be given intraveneously at this time.

[gas_dr]

Bamlanivomab is pretty good
Regeneron is excellent

And despite what the Quoctors say ivermectin is not a cure nor is it as good as the monoclonal therapies.

[EinNYC]

Do Not Want.

[SeekAndFind]

RE: Do Not Want.

What do you want then?

[mrsmith]

Yeah, Regeneron requires infusion at this time. an expensive treatment!

https://www.nature.com/articles/d41586-021-01481-2
“A nasal spritz of a designer antibody offers strong protection against variants of the coronavirus SARS-CoV-2 — at least in mice1.”

[SeekAndFind]

RE: ivermectin is not a cure nor is it as good as the monoclonal therapies.

If you were in charge, what do you propose to do to make this monoclonal antibody available on an outpatient basis to everyone as soon as Covid symptoms develop? The goal of course is to avoid burdening hospitals.

[mrsmith]

That’s a tough query!
I’ll watch the response too.

Other Mabs are effective against other variants too btw.

[gas_dr]

If I were in charge every testing site would have monoclonal available. At this tome you have to get to an infusion center. Within 10 days is at prom onset.

I would also widely distributed the monoclonal to primary care physician offices and revise CPT codes to those doctors to allow reimbursement for the infusion procedure. Every doctors office has an MA or RN that could start an IV. Reimburse them for it.

What difference does it make if one or 15 centers get reimbursement. It’s just the patients would be more diluted through the system but the overall savings to health care would be enormous.

The issue currently issue is that we have monoclonals languishing on the shelf. It has not been well promoted. If the antivaxxer crowd really wanted to make inroads into the EUA which requires an efficacious treatment then they would be screaming at the top of their lungs for widespread distribution of these on target therapeutics instead of the weak ivermectin and discredited HCQ therapies.

The problem is the distribution and paperwork to get people to these therapies. As on anything reduce the bureaucracy and improve the delivery to the patient.

[Karliner]

And Regen is about 3K a pop compared to Ivermectin’s approx60 bucks for 20 day supply.

[EinNYC]

This is most likely just another one of these state sanctioned “vaccines”. One wonders just why they are being pushed so hard. It’s not like we’ve never had other contagious and deadly viruses before, but never in history has a vaccine been pushed to hard, whether by carrot or stick.

[SeekAndFind]

RE: This is most likely just another one of these state sanctioned “vaccines”.

Except it isn’t a vaccine, it is a therapy. It was one of the first treatment President Trump received when he went to Walter Reed. He himself testified that he felt relief and the Covid Symptoms disappeared overnight after he was treated with it.

[SeekAndFind]

RE: If I were in charge every testing site would have monoclonal available. At this tome you have to get to an infusion center. Within 10 days is at prom onset.

There is also the issue of COST.

Do you propose to make this FREE for everyone (Subsidized by government like they do the vaccines )?

[mrsmith]

Thanks.

[Mom MD]

I think we should take a holiday and out the experts in free republic i. charge of treatment. They can report for duty to the ICU near them and assume care for the patients. Since they will have them all cured in days and no one else will ever get sick with covid again under their care we can take a nice long summer vacation

[ProtectOurFreedom]

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.

This seems like a HUGE breakthrough in treatment. Being able to give a simple 1,200 mg injection at any doctor's office rather than 2,400 mg at an infusion center should make this a lot more widely available.

[gas_dr]

It actually is already free for everyone.