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COVID-19 Antibody Treatment Approved for Unvaccinated Family Members With Weak Immunities


Monoclonal Antibody Treatments Defined
The new treatment was initially allowed for limited use and administered as an IV infusion cocktail, alongside medications like casirivimab and imdevimab, within ten days of the patient's symptoms manifestation. However, with the FDA's newest approval, the treatment may now be administered within 96 hours after the exposure.
To gain clearance from the FDA, the pharmaceutical company had a clinical trial among a larger group composed of families exposed to contacts with COVID-19 in the U.S. Moldova and Romania. Of the 1,505 participants, 81 percent who took the cocktail had reduced risks of hospitalization and severe symptoms from the virus. The affected patients also had shorter symptoms of the virus clearing faster than if they did not get the IV infusion.

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Regeneron's antibody drug can help prevent covid-19 from spreading among household members


The Philadelphia Inquirer
Star Tribune
Vials are inspected at Regeneron Pharmaceutical’s facilities in New York state, for efforts on an experimental coronavirus antibody drug.
 
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PHILADELPHIA — Drugs that can keep high-risk covid-19 patients out of the hospital are going begging because the supposed breakthrough treatments require an hour-long intravenous infusion and offer a rather small chance of benefit.
On Monday, Regeneron announced results that may help make its monoclonal antibody combination, now branded REGEN-COV, more useful. The drug combo was given in a single shot and dramatically reduced the chance of infection in unvaccinated individuals living with someone newly diagnosed with covid-19.

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Phase 3 Treatment Trial in Recently Infected Asymptomatic Patients Showed REGEN-COV™ (casirivimab with imdevimab) Significantly Reduced Progression to Symptomatic COVID-19


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TARRYTOWN, N.Y., April 12, 2021 /PRNewswire/ --
Second Phase 3 trial undertaken in collaboration with NIAID to announce results today, both using subcutaneous administration of REGEN-COV in asymptomatic individuals without prior COVID-19 infection
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive data from a Phase 3 trial (2069B) of recently infected asymptomatic COVID-19 patients, evaluating REGEN-COV™ (casirivimab with imdevimab) 1,200 mg administered via subcutaneous (SC) administration. REGEN-COV reduced the overall risk of progressing to symptomatic COVID-19 by 31% (primary endpoint), and by 76% after the third day. The trial also demonstrated that REGEN-COV shortened symptom duration and markedly reduced viral levels.
The Phase 3 trial is the second to report results today, which was jointly run with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The trial enrolled 204 individuals without any COVID-19 symptoms who tested positive for SARS-CoV-2 but did not have anti-virus antibodies at baseline, and were randomized to receive either 1 dose of REGEN-COV (1,200 mg) or placebo.

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Regeneron COVID-19 antibody cocktail helps prevent symptomatic disease in study


Infectious disease doctor Dr. Amesh Adalja on several states see spike in coronavirus cases.
A monoclonal antibody cocktail developed by Regeneron and Roche dropped the risk of symptomatic COVID-19 by up to 76% after three days for recently infected individuals not yet experiencing symptoms, according to a press release posted Monday. The drug, REGEN-COV, also significantly reduced duration of symptoms and lowered viral levels, Regeneron said.
REGEN-COV, comprised of casirivimab with imdevimab, has already received emergency use authorization from the FDA in the U.S. Under the current EUA, the combo therapy is approved to treat non-hospitalized adults and adolescents with mild to moderate symptoms of COVID-19 and who are at high risk for developing severe symptoms or the need for hospitalization.

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Regeneron to seek US OK for COVID-19 cocktail to be used for prevention


ZURICH (Reuters) — Regeneron is pursuing U.S. approval for its COVID-19 monoclonal antibody cocktail as a preventative treatment after it helped cut the risk of symptomatic infections in households where someone else is ill, the U.S. drugmaker said on Monday.
REGEN-COV, a combination of casirivimab and imdevimab, protected household contacts from exposure to SARS-CoV-2, with 72% protection against symptomatic infections in the first week and 93% after that, according to trial data released by the company.
In a separate trial, Regeneron also said the treatment reduced overall risk of progressing to symptomatic COVID-19 by 31% and by 76% after the third day.
Regeneron has enlisted Switzerland's Roche and its massive biotech facility in South San Francisco to make around 2 million doses annually. The cocktail already has emergency U.S. approval for mild to moderate COVID-19 patients, and the companies are hoping the latest trials convince regulators to expand deployment.

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Regeneron COVID-19 Cocktail Shows Promise as Preventative Treatment

Regeneron says its Regen-COV antibody cocktail may work well at treating people who have been exposed to COVID-19 but are not showing symptoms.

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