Another potential drug for COVID-19 is expected to be on the market, GSK/Vir submitted an emergency use authorization application for monoclonal antibody VIR-7831

Recently, GlaxoSmithKline (GSK) and Vir Biotechnology have jointly announced that they have submitted an emergency use authorization (EUA) for the monoclonal antibody drug VIR-7831 (GSK4182136) to the U.
S.
Food and Drug Administration (FDA) for use in Treat mild or moderate COVID-19 patients over 12 years old (within 40 kg) who may be at risk of hospitalization or death.

According to information published by GSK and Vir, VIR-7831 is a dual-acting SARS-CoV-2 monoclonal antibody, based on Xencor's Xtend™ technology, which can block the virus from invading healthy cells and clear the infection.
cell.

A study published in the international journal "bioRxiv" pointed out that compared with other monoclonal antibodies, VIR-7831 can bind to the highly conserved epitope of the SARS-CoV-2 spike protein, effectively fighting against the United Kingdom, South Africa and Brazil's new coronavirus (SARS-CoV-2) variants prevent the body from developing drug resistance.

https://doi.
org/10.
1101/2021.
03.
09.
434607 It is understood that the emergency use authorization (EUA) application of VIR-7831 is based on an interim analysis of the safety and effectiveness of a phase III clinical trial.

The trial enrolled a total of 583 COVID-19 patients.
Clinical data showed that compared with the placebo group (292 cases), the number of hospitalizations or deaths of patients receiving VIR-7831 monotherapy (291 cases) was reduced by 85%, and the number of patients Well tolerated.

In March of this year, in view of the remarkable curative effect of VIR-7831, the Independent Data Monitoring Committee (IDMC) recommended that the phase III clinical trials of the drug should be terminated as soon as possible so that the drug can be used for the treatment of COVID-19 patients as soon as possible.

At the same time, GlaxoSmithKline (GSK) and Vir Biotech will submit a biologics license application (BLA) to the U.
S.
Food and Drug Administration (FDA) based on phase III clinical trial data.

It is worth mentioning that Eli Lilly and Regeneron's COVID-19 "antibody cocktail therapy" obtained emergency use authorization from the U.
S.
Food and Drug Administration as early as November last year, but U.
S.
officials revealed that due to the The therapy requires intravenous injection within a short period of time when the patient has symptoms to be effective, so it has not been widely used in the market.

At present, although the research progress of VIR-7831 lags behind the "antibody cocktail therapy" of Eli Lilly and Regeneron, GSK and Vir said they plan to launch two new phase III clinical trials COMET in the second quarter of this year.
-TAIL and COMET-STAR, on the one hand, assess whether VIR-7831 will reduce the hospitalization rate or mortality of adult patients at high risk of COVID-19, and on the other hand, assess whether high-risk uninfected adults can receive VIR-7831 intervention.
Prevent the occurrence of COVID-19.

In the future, GSK and Vir will continue to discuss with the European Medicines Agency (EMA) and other regulatory agencies around the world to promote the launch of VIR-7831 as soon as possible.

End reference materials: [1]