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Virus World

Virus World provides a daily blog of the latest news in the Virology field and the COVID-19 pandemic. News on new antiviral drugs, vaccines, diagnostic tests, viral outbreaks, novel viruses and milestone discoveries are curated by expert virologists. Highlighted news include trending and most cited scientific articles in these fields with links to the original publications. Stay up-to-date with the most exciting discoveries in the virus world and the last therapies for COVID-19 without spending hours browsing news and scientific publications. Additional comments by experts on the topics are available in Linkedin (https://www.linkedin.com/in/juanlama/detail/recent-activity/)
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Covid Updates: Glaxo Antibody Drug Is Restricted in the Northeast - The New York Times

Covid Updates: Glaxo Antibody Drug Is Restricted in the Northeast - The New York Times | Virus World | Scoop.it
From www.nytimes.com - March 26, 2022 11:28 PM

Federal health officials on Friday restricted use of a Covid monoclonal antibody drug in eight states in the Northeast and two territories, citing evidence that it is unlikely to be effective against the highly transmissible Omicron subvariant known as BA.2 that is now dominant in those regions and quickly gaining ground across the country. The federal government said it would immediately pause shipments of the infused treatment, known as sotrovimab, to the 8 affected states, and Puerto Rico and the U.S. Virgin Islands. The Food and Drug Administration said the drug is no longer authorized for use in those places. The move, likely to soon extend to other parts of the country as BA.2 continues to spread, leaves doctors in the Northeast with one fewer option to treat high-risk Covid patients at the same time that a funding crunch is narrowing the menu of treatments. With an aid package in Congress stalled, the Biden administration is out of money for more antibody treatments and was forced to reduce shipments this week. For now, physicians treating high-risk patients still have access to one monoclonal antibody drug, known as bebtelovimab and made by Eli Lilly, as well as three antiviral treatments, though the funding shortfall threatens future shipments and orders of some of the drugs. Those remaining therapies have been found in laboratory tests to retain potency against BA.2.

 

Sotrovimab had been widely used in recent months because it was the only authorized antibody treatment that worked against BA.1, the Omicron subvariant that was responsible for the massive surge in cases. This past winter, federal officials restricted use of two other antibody treatments, from Eli Lilly and Regeneron, that had been widely used during the Delta surge because they were not potent against BA.1. Those drugs are not expected to work against BA.2, either. Sotrovimab’s manufacturers, GlaxoSmithKline and Vir Biotechnology, said on Friday that their laboratory testing had found that the authorized dosage of the drug was not sufficiently potent against BA.2, matching earlier findings from independent researchers. The drug makers said they were preparing to submit data to regulators for a higher dose of the drug, which is currently given as an intravenous infusion at 500 milligrams, that they hope will work against BA.2.

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good health's curator insight, January 10, 8:17 AM

Acquista Online La Prescrizione Di Perdita Di Peso
Crediamo che i farmaci a volte possano essere molto urgenti da assumere. Se hai urgente bisogno di farmaci, possiamo anche fornirti una consegna espressa,


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Vir, GSK COVID-19 Antibody Slashes Hospitalizations and Deaths in Phase 3, Spurring FDA Filing Plans

Vir, GSK COVID-19 Antibody Slashes Hospitalizations and Deaths in Phase 3, Spurring FDA Filing Plans | Virus World | Scoop.it
From www.fiercebiotech.com - March 13, 2021 11:10 AM

Vir Biotechnology and GlaxoSmithKline are stopping a phase 3 clinical trial of their COVID-19 antibody early for efficacy after seeing an 85% reduction in hospitalization or death at an interim review. The trial provided further evidence of the efficacy of anti-SARS-CoV-2 antibodies in ambulatory patients.  As of the interim review, 583 people recently infected with COVID-19 had received VIR-7831, also known as GSK4182136, or placebo. The participants were all at high risk of progression, based on their age or other factors, but were unlikely to require hospitalization in the next 24 hours and had oxygen saturation of 94% or greater at the time of enrollment. In those patients, the anti-SARS-CoV-2 antibody reduced the number of patients who died or needed hospitalizing for more than 24 hours in the 29 days after randomization by 85%. The effect was large enough to prompt the independent data monitoring committee to recommend stopping enrollment.     The study remains blinded while Vir and GSK complete the 24 weeks of follow-up on patients already in the study. Vir and GSK plan to share additional data once the clinical trial is complete but already see enough promise to outline plans to seek emergency use authorization in the U.S. and equivalent approvals in other markets.

 

It is unclear how large a market awaits Vir and GSK if they win approval. At the peak of the winter wave of COVID-19 cases in the U.S., supplies of other anti-SARS-CoV-2 antibodies from Eli Lilly and Regeneron were going unused, in part due to the difficulties of organizing infusions.  Those difficulties were present when trying to use antibodies to treat recently hospitalized patients. Vir and GSK are targeting the high-risk, pre-hospitalization market. Anti-SARS-CoV-2 antibodies seem to work in the population—Eli Lilly presented similar data to Vir and GSK on its therapy—but the need to identify high-risk patients and quickly arrange infusions could limit use. In some markets, the cost of the antibodies may also be a barrier to use.  Vir and GSK are working to reduce the administration barriers by developing an intramuscular formulation of their antibody. A phase 3 trial of the formulation in high-risk adults is due to start in the second quarter. If effective, the intramuscular formulation could play a role in the longer-term response to COVID-19 given evidence VIR-7831 binds to a highly conserved epitope of the spike protein and is effective against current variants of concern.  Whatever the commercial potential of the product, the phase 3 data still mark a big moment for Vir in scientific terms. The phase 3 trial is the strongest evidence yet that Vir’s platform can generate antibodies that treat viral infections, delivering a boost to its broader plans in infectious diseases.   Shares in Vir soared 35% after publication of the top-line phase 3 data.

 

GSK/Vir Press Release (March 0, 2021):

 https://www.gsk.com/en-gb/media/press-releases/vir-biotechnology-and-gsk-announce-vir-7831-reduces-hospitalisation-and-risk-of-death-in-early-treatment-of-adults-with-covid-19/

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U.S. FDA Gives Emergency Use Approval for GSK-Vir COVID-19 Antibody Drug

U.S. FDA Gives Emergency Use Approval for GSK-Vir COVID-19 Antibody Drug | Virus World | Scoop.it
From www.reuters.com - May 27, 2021 2:22 AM

The U.S. Food and Drug Administration gave an emergency use authorization to the antibody treatment developed by Vir Biotechnology (VIR.O) and GlaxoSmithKline (GSK.L) for treating mild-to-moderate COVID-19 in people aged 12 years and older.  The antibody drug, Sotrovimab, is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy, the health regulator said on Wednesday. (https://bit.ly/3uorQZ8) Sotrovimab belongs to a class of drugs called monoclonal antibodies, which mimic natural antibodies that the body generates to fight off infection. The antibody treatment will be available for COVID-19 patients in the coming weeks, GSK and Vir said, adding that they plan to submit a marketing application to the FDA in the second half of 2021.  Similar COVID-19 therapies by Regeneron Pharmaceuticals (REGN.O) and Eli Lilly (LLY.N) have been authorized for emergency use in the United States. The European Union's drug regulator last week backed the use of Sotrovimab for COVID-19 patients who were at risk of severe disease and do not need supplemental oxygen.

 

FDA Emergency Use Authorization Letter (May 26, 2021):

https://www.fda.gov/media/149532/download 

 

Glaxo Press Release (May 26, 2021):

https://www.gsk.com/en-gb/media/press-releases/vir-biotechnology-and-gsk-announce-vir-7831-reduces-hospitalisation-and-risk-of-death-in-early-treatment-of-adults-with-covid-19/ 

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