Ik heb onderstaande artikel mede gebaseerd op dit artikel van Maurice de Hondt

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20 december 2021: Bron: EMA

Tussen 30 juni en 13 juli werd Sotrovimab - Xevudy toegediend aan 6.175 patiënten met het coronavirus - Covid-19 aan patiënten die al waren besmet met het coronavirus. Ongeveer 52 procent van de patiënten was 50 jaar of ouder en bijna alle patiënten hadden meerdere onderliggende ziektes, waaronder obesitas, kanker, hart- en vaatziekten en diabetes.

Volgens de officiele medische autoriteiten van Abu Dhabi waar deze studie is uitgevoerd waren dit de resultaten:

97 procent van de patiënten die Sotrovimab - Xevudy kreeg toegediend via een infuus herstelde volledig binnen 14 dagen. De medicatie resulteerde ook in 100 procent preventie van overlijden onder de patiënten en 99 procent preventie van opname op de IC. 

O.a. deze studie uit Abu Dhabi, maar er zijn er meer gedaan met Sotrovimab - Xevudy zelfs al met een prik in de arm en niet via infuus, zijn aanleiding voor de EMA om op basis van hun rolling review dat zij startten mei 2021 nu goedkeuring voor algemeen gebruik goed te keuren voor eind december 2021.

Zie dit laatste persbericht van de EMA

EMA receives application for marketing authorisation for Xevudy (sotrovimab) for treating patients with COVID-19

 
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News 18/11/2021

EMA has started evaluating an application for marketing authorisation for the monoclonal antibody Xevudy (sotrovimab). The applicant is GlaxoSmithKline Trading Services Limited, who developed the medicine together with Vir Biotechnology.

Xevudy is intended for the treatment of adults and adolescents with COVID-19 who do not require supplemental oxygen therapy and who are at increased risk of progressing to severe COVID-19. 

EMA will assess the benefits and risks of Xevudy under a reduced timeline and could issue an opinion within two months, depending on whether the data submitted are sufficiently robust and whether further information is required to support the evaluation. 

Such a short timeframe is only possible because EMA’s human medicines committee (CHMP) has already reviewed some data on the medicine during a rolling review. During this phase, CHMP assessed data from laboratory studies and animal studies, as well as data on the quality of the medicine. In addition, CHMP assessed data from a study into the effects of sotrovimab in adult outpatients with mild COVID-19 symptoms who do not need supplemental oxygen and who are at increased risk of their disease becoming severe.¹

In parallel, EMA’s safety committee (PRAC) completed the preliminary assessment of the risk management plan (RMP) proposed by the company, which outlines measures to identify, characterise and minimise the medicine’s risks. Furthermore, EMA’s committee for medicines for children (PDCO) issued its opinion on the company’s paediatric investigation plan (PIP), which describes how the medicine should be developed and studied for use in children, in accordance with the accelerated timelines for COVID-19 products. 

Should the additional data now submitted with the marketing authorisation application be sufficient for CHMP to conclude that the benefits of Xevudy outweigh its risks in the treatment of COVID 19, EMA will liaise closely with the European Commission to fast track the decision granting a marketing authorisation in all EU and EEA Member States.

EMA will communicate further at the time of the CHMP’s opinion. 

How is the medicine expected to work?

Sotrovimab (also known as VIR-7831 and GSK4182136) is a monoclonal antibody with activity against COVID-19. A monoclonal antibody is a type of protein that attaches to a specific structure (called an antigen). Sotrovimab is designed to attach to the spike protein of SARS-CoV-2, the virus that causes COVID-19. When it attaches to the spike protein, the ability of the virus to enter the body’s cells is reduced. This is expected to reduce the severity of the disease and the need for hospitalisation in patients with COVID-19.


Hier enkele studies en artikelen en klik door op de links in dit artikel: 

Sotrovimab (Xevudy) Anti-SARS-CoV-2 Antibody Description

Sotrovimab (Xevudy®) (VIR-7831, GSK4182136) is a pan-sarbecovirus anti-SARS-CoV-2 monoclonal antibody selected based on its potential to neutralize the betacoronavirus in vitro, kill infected cells, provide a high barrier to resistance, and achieve high concentrations in the lungs (one of the essential sites of infection).

The Sotrovimab antibody therapy binds to an epitope on SARS-CoV-2 shared with SARS-CoV-1 (SARS). In preclinical trials, the antibody has shown the ability to neutralize the SARS-CoV-2 live virus by binding to an epitope on SARS-CoV-2 shared with SARS-CoV-1, indicating that the epitope is highly conserved, which may make it more difficult for escape mutants to develop.

Vir Biotechnology and GSK are advancing Sotrovimab (VIR-7831) due to their collaboration to research and develop solutions. Sotrovimab, sold under the brand name Xevudy. The Companies published 'A Detailed Guide for the Use of Sotrovimab' in July 2021.


The U.S. FDA's EUA issued on May 26, 2021, allows for Sotrovimab to be distributed and administered as a 500-milligram single dose intravenously by health care providers.

The data that support the EUA for sotrovimab came from the Phase 3 COMET-ICE trial. On November 12, 2021, the companies confirmed the final COMET-ICE trial results in the full study population of 1,057 participants, demonstrating a 79% reduction in hospitalization and death at Day 29 vs. placebo.

On September 1, 2021, the Fact Sheet for Healthcare Providers has updated; the FDA Letter of Authorisation and the full Fact Sheet for Patients, Parents, and Caregivers. In addition, on October 8, 2021, the updated FDA EUA provided a comprehensive list of medical conditions or other factors as criteria for using anti-SARS-CoV-2 mAbs as treatment or PEP.

The U.S. NIH updated COVID-19 Treatment Guidelines on the Emergency Use Authorizations of Anti-SARS-CoV-2 Monoclonal Antibodies for the Treatment of COVID-19.

CAS Number: 2423014-07-5; Drugbank: DB16355; UNII: 1MTK0BPN8V; KEGG: D12014

Sotrovimab (Xevudy) Anti-SARS-CoV-2 Antibody Authorizations

The European Medicines Agency (EMA) advised using sotrovimab (VIR-7831) to treat COVID-19 on May 21, 2021. The EMA's human medicines committee started a 'rolling review' of data on sotrovimab (VIR-7831 and GSK4182136) on July 5, 2021. In addition, EMA began evaluating an application for marketing authorization for the monoclonal antibody Xevudy (sotrovimab) submitted by GlaxoSmithKline Trading Services Limited on November 18, 2021.


 

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