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.
I was responding to someone who said ivermectin is useful in severe illness. It is marginal early. I guess you reject the experience of a Freeper who posted his personal experience and it was not good.
Quit cherry picking the narrative. You are living prof that faucets are the entry to the sewer
Many Christians disagree with you
I’ve been here all along just lest vocal because the group think has achieved impenetrable.
“you’re trying to exempt from your guilt by association game”
You seem to be all about rationalizing use of aborted baby parts to avoid any cognitive dissonance over it.
“HEK has been used to test common OTC meds like aspirin and ibuprofen.”
Apparently true in some cases, but long after-the-fact (subsequent to development) and obviously not central to the development process. Obviously something that occurs 100 years after development (aspirin), by independent third parties, does not fatally taint the product.
I’m not well-versed on the subject, but monoclonals did save a good friend of mine’s life in 2021, so there’s that.
Just-as-effective, alternative therapeutics such as monoclonal antibodies and ivermectin could not be approved by “health agencies” and by unelected bureaucrats lest the “vaccine” mandates be rescinded as required by law.
I was wrong! Oh no. I am sorry.
It is a humanized MAB. Thank you for the corrections.
I did that. Worked one through clinical trials while employed by a big pharma.
Made mabs. But mine were chimera, not humanized.
And I am retired now from the bench...so probably falling behind..
Thanks again. First time I have heard of an MAB
labeled a receptor antagonist.
Why Roche's is being touted an an anti-inflammatory...?
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