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Health & Fitness WHO recommends Regeneron's Covid antibody treatment

04:30  24 september  2021
04:30  24 september  2021 Source:   dailymail.co.uk

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Learn how Regeneron is actively working on testing existing medicines and developing new antibodies to combat the COVID -19 pandemic. Our COVID -19 antibody program. REGEN-COV™ (casirivimab and imdevimab) eligibility and access sites. Ongoing clinical and preclinical research. Peer-reviewed research. Our antibody cocktail approach to infectious disease. Regeneron is applying our 30 years of scientific and technology expertise to combat the COVID -19 pandemic.

Sept 24 (Reuters) - A World Health Organization ( WHO ) panel on Friday recommended the use of Regeneron (REGN.O) and Roche' s (ROG. S ) COVID -19 antibody cocktail for patients at high risk of hospitalisations and those severely ill with no natural antibodies . While acknowledging costs associated with the treatment , the WHO panel said that given the recorded benefits of the therapy, "the recommendations should provide a stimulus to engage all possible mechanisms to improve global access to the intervention and associated testing."

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A panel of international experts representing the World Health Organization (WHO) has recommended high-risk COVID-19 patients receive Regeneron's monoclonal antibody treatment to reduce their risk of severe disease.

Regeneron's treatment - which the U.S. Food & Drug Administration (FDA) authorized in the U.S. in November - includes two antibodies, called casirivimab and imdevimab, that can boost patients' immune systems.

WHO recommends this treatment for two groups of patients: those who don't have severe Covid but are at high risk of hospitalization, and those who have severe Covid and fail to test positive for coronavirus antibodies.

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The treatment should be given to patients who have a positive coronavirus test and face a high risk of getting severe COVID -19, including those who are 65 and older or have certain chronic medical conditions. “Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and Earlier this month, the FDA also authorized Eli Lilly’ s antibody treatment -- called bamlanivimab -- for people who have COVID -19 and have a high risk of getting a severe form of the disease. “The emergency authorization of these monoclonal antibodies administered together offers

Adaptive COVID -19 treatment trail (ACTT) designed to evaluate an experimental treatment for COVID -19 sponsored by the National Institute of Allergy and Infectious Diseases ( NIAID ) was a clinical trail which began on February 21, 2020. ACTT was a double blind placebo controlled ( RDBPC ) study, the ‘gold The US ( FDA ) on May 1, 2020 approved emergency use of Remdesivir in patients with severe COVID -19. Committee for Medicinal Products for Human Use (CHMP) in European Union has recommended the compassionate use of Remdesivir based on the preliminary results of the ACTT.

Still, the WHO panel acknowledges this treatment may be difficult to administer in low- and middle-income countries, due to its cost and equipment requirements.

It is even difficult to access in some U.S. states, due to new federal distribution protocols after just seven states comprised 70 percent of treatment orders.

The WHO has recommended Regeneron's monoclonal antibody treatment, which boosts Covid patients' immune systems. Pictured: A box and vial of Regeneron's treatment at a treatment site in Orlando, Florida, August 2021 © Provided by Daily Mail The WHO has recommended Regeneron's monoclonal antibody treatment, which boosts Covid patients' immune systems. Pictured: A box and vial of Regeneron's treatment at a treatment site in Orlando, Florida, August 2021 High-risk patients include those who don't have severe Covid but are at high risk of hospitalization, and those who have severe Covid and fail to test positive for coronavirus antibodies © Provided by Daily Mail High-risk patients include those who don't have severe Covid but are at high risk of hospitalization, and those who have severe Covid and fail to test positive for coronavirus antibodies

Monoclonal antibody treatments have been a popular strategy for treating Covid patients in the U.S., especially during the country's recent surge.

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Regeneron starts Phase 3 trial of Covid antibody drug that might treat and prevent infection, company says. Marrazzo said what stood out to her is that the study characterized patients by their immune responses prior to treatment and determined who did and did not benefit. "What I think is Human trials expected to start next month for Covid -19 treatment derived from cows' blood. "It came in exactly the way we expected it to work," Schleifer said. Dr. Claudia Hoyen, an infectious disease specialist with University Hospitals Cleveland Medical Center, also sees the results as "promising."

Regeneron submitted an emergency use application that month after preclinical studies showed that the therapy, called REGN-COV2, reduced the amount of virus and associated damage in the lungs of non-human primates. Regeneron ' s therapy is part of a class of treatments known as monoclonal antibodies , which are made to act as immune cells that The Food and Drug Administration on Saturday granted an emergency use authorization for Regeneron ' s Covid -19 antibody treatment , the experimental therapy given to President Donald Trump when he contracted the coronavirus in October.

In this treatment, a patient receives an infusion of synthetically-made antibodies - immune system proteins - that are designed specifically to fight the coronavirus.

If a patient is given this infusion soon after they become infected with the coronavirus, those synthetic antibodies can boost their immune system and ward off severe disease.

Data from the U.S. show that the treatment can help keep patients out of the hospital or, if they are hospitalized, it can help keep them out of intensive care units.

Former President Trump was treated with monoclonal antibodies when he contracted Covid in October 2020.

The FDA gave a monoclonal antibody treatment made by the drug company Regeneron in Emergency Use Authorization in November.

Now, a panel of experts representing the WHO has followed suit in recommending Regeneron's treatment for patients globally.


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Regeneron last week reported results from a late-stage study indicating its antibody cocktail was effective in preventing COVID -19 in people exposed to those infected with the new coronavirus. The therapy received an emergency use authorization from the U. S . Food and Drug Administration in Edesa Biotech Inc (NASDAQ: EDSA) is surging higher Monday after the company announced positive Phase 2 data of its monoclonal antibody in hospitalized COVID -19 patients. Critically ill patients demonstrated a 68.5% reduction in the risk of dying when treated with EB05 over standard of care.

The World Health Organization ( WHO ) welcomes the addition of another therapeutic to the world’ s arsenal against COVID -19, but urges producing companies and governments to address the high price and limited production of the Regeneron antibody combination and ensure safe and appropriate handling of the ACT-A partners are also working with WHO on an equitable access framework for recommended COVID -19 therapeutics. WHO also calls for the sharing of technology to allow for the manufacturing of biosimilar versions so all patients who may need this treatment have access to it.

Regeneron's treatment includes two types of antibodies, called casirivimab and imdevimab. The antibody types work together to boost patients' immune systems.

The WHO panel recommended this antibody treatment for two groups of patients.

The first group: patients who do not have a severe case of Covid, but may be at risk for developing severe symptoms due to their age, comorbidities, or other factors.

This recommendation is based on studies showing that Regeneron's treatment reduces the risk of hospitalization for such patients, by making their symptoms less severe.

In addition, the WHO recommended that Regeneron's treatment may be used for patients who have a severe case of Covid - but test negative for coronavirus antibodies, indicating that their immune system is not responding to the virus.

This second recommendation is based on data from a large trial, showing that the antibody treatment can boost the immune system response in critically ill patients.

For critically ill patients, Regeneron's treatment can reduce the risk of death or requiring mechanical ventilation.

Stem cell transplant recipients develop high antibodies after 2 doses

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For other Covid patients, however, the WHO panel says that this treatment is less likely to have a significant impact.

Monoclonal antibody treatments are easier to access in the U.S. than in other countries. Pictured: A nurse prepares to administer Regeneron's treatment at an urgent care center in Sarasota, Florida, September 2021 © Provided by Daily Mail Monoclonal antibody treatments are easier to access in the U.S. than in other countries. Pictured: A nurse prepares to administer Regeneron's treatment at an urgent care center in Sarasota, Florida, September 2021

The WHO guidance is part of a living, often-updated guide to treating Covid, available at the journal BMJ.

In the guidance, the WHO experts acknowledged that it may be difficult for low- and middle-income countries to take advantage of Regeneron's treatment, which costs $2,100 for one dose.

These nations may not have access to serological tests needed for prescribing the treatment, or to the intravenous equipment needed to administer the treatment.

In addition, the treatment may become less effective in future months if new variants emerge that are resistant to synthetic antibodies.

Regeneron's treatment is currently difficult to access in some parts of the U.S., in fact, as the Department of Health and Human Services (HHS) has restricted its use due to recent supply concerns.

Last week, the HHS announced that it would control monoclonal antibody supplies because just seven states were making up 70 percent of orders for the treatment.

States such as Florida, which made monoclonal antibodies widely available through state-run clinics, are now facing high demand for the treatment.

The federal government is encouraging vaccines over monoclonal antibodies.

The cost of one monoclonal antibody dose is approximately 100 times the cost of one vaccine dose.

  WHO recommends Regeneron's Covid antibody treatment © Provided by Daily Mail Read more

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