GSK and Vir Submit FDA Application to Expand EUA for Sotrovimab to Include Intramuscular Administration in Early COVID-19 Treatment

News on January 19, 2022 /BioValleyBIOON/ -- According to Baidu's "Real-time Updates on the COVID-19 Pandemic"Big DataReport》，As of 00:00 on January 19, 2022, the global cumulative confirmed cases exceeded 330 million (332.13 million), with over 5.56 million deaths.

Recently,GSK(GSK) and Vir Biotechnology, Inc. jointly announced that they have submitted to the U.S. Food and Drug Administration (FDA) Submit an application to amend the Emergency Use Authorization (EUA) for sotrovimab,Including Intramuscular (IM) Administration。

Sotrovimab is a monoclonal antibody drug used for the early treatment of COVID-19. In May 2021,FDAGranting sotrovimab EUA: As a single-dose intravenous infusion (IV, 500mg) therapy for the early treatment of COVID-19. GSK and Vir have requested an EUA expansion to include an IM administration (500mg) option.

Under the current EUA, sotrovimab can be used to treat mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older, weighing at least 40 kg) who are at high risk, specifically: patients with positive results from direct SARS-CoV-2 viral testing and at high risk of progressing to severe COVID-19 (including hospitalization and death).

This application is based on the results of the randomized, open-label, non-inferiority Phase 3 COMET-TAIL trial. The trial recruited participants during the Delta variant pandemic in the United States and met its primary endpoint, with data confirming:When used for the early treatment of mild to moderate COVID-19 in high-risk, non-hospitalized adults and adolescents (≥12 years), sotrovimab 500mg IM (n=376) is non-inferior to sotrovimab 500mg IV (n=378), with similar efficacy between the two administration methods.

The COMET-TAIL trial aims to evaluate the efficacy, safety, and tolerability of sotrovimab administered via two methods (IM, IV) within 7 days of symptom onset in high-risk patients.During the 29 days of the trial, 2.7% of patients in the IM administration group (500mg) progressed to hospitalization for more than 24 hours or death, compared to 1.3% in the IV administration group (500mg). The adjusted difference between the two groups was 1.07% (95% CI: -1.25% to 3.39%).. The upper limit of the 95% CI is in the United StatesFDAThe primary endpoint of the trial, determined through consultation, was preset within a non-inferiority margin of 3.5%. Additionally, the incidence of serious adverse events was low (≤1% in both groups).

Sotrovimab is a monoclonal antibody with dual action, having the potential to both block the virus from entering healthy cells and clear infected cells. Sotrovimab is able to bind to an epitope shared by SARS-CoV-2 and SARS-CoV-1 (the virus that causes SARS), which is highly conserved, potentially making the development of resistance more difficult. Sotrovimab incorporates Xencor's Xtend technology and is also designed to achieve high concentrations in the lungs to ensure optimal penetration of the airway tissues affected by SARS-CoV-2, with an extended half-life.

In the EU, sotrovimab (Xevudy) was approved in December 2021 for the early treatment of COVID-19. Xevudy is indicated for the treatment of adults and adolescents (aged ≥12 years and weighing ≥40 kg) who do not require supplemental oxygen and are at increased risk of progressing to severe COVID-19. Additionally, sotrovimab has received conditional approval in the UK and temporary authorization in several other countries.

In recognition of the urgent needs of patients around the world, GSK and Vir are collaborating with governments and procurement organizations to provide sotrovimab in support of the response to the COVID-19 pandemic. GSK and Vir have signed supply agreements with multiple governments worldwide and will continue their efforts as the pandemic evolves.

GSK and Vir Biotechnology are committed to the ongoing evaluation of sotrovimab, as the landscape of COVID-19 continues to evolve globally at varying rates, with new variants emerging. Updated in vitro data published on the preprint server bioRxiv indicate that sotrovimab retains activity against all currently tested viral variants of concern and interest defined by the WHO, including but not limited to Omicron (B.1.1.529), Delta (B.1.617.2), Delta Plus (AY.1 or AY.2), and Mu (B.1.621). (Bioon.com)

Source of the original text:GSK and Vir Submit Emergency Use Authorization Application to FDA for Intramuscular Administration of Sotrovimab for the Early Treatment of COVID-19