Posted on 12/23/2022 6:38:16 PM PST by SeekAndFind
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.
ping
Sure, trust the FDA.
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...
Made from humanized mice installed with dead baby body parts. No thanks.
In severe illness ivermectin is wortthless
Completely untrue. Because you choose not To have it should it be necessary doesn’t mean you should deny others based on hyperbolic falsehoods
Thanks for the ping. This is good news
Tocilizumab is an IL-6 inhibitor and we’ve been using it (or baricitinib) since the Fall of 2020.
“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.)
“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.
Now that no one needs it any longer
I have lost complete trust in all of them. I’ll never get a shot for anything ever again
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.
Ping
Hyperbolic falsehoods? Prove me wrong.
“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.
Welcome back! We’ve missed you!
The involvement of HEK-293 in testing a drug disqualifies that drug for use by an ethical Christian. We’re kooks.
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.
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