GSK building

EMA begin review of GSK & Vir COVID-19 treatment

pharmafile | May 10, 2021 | News story | Sales and Marketing COVID-19, EMA, GSK, covid-19 treatment, pharma, pharma news, vir 

The EMA has begun a rolling review of GSK and Vir’s sotrovimab treatment for COVID-19, which will continue until there is enough evidence available for a marketing authorisation application for the drug.

The review will evaluate the treatment in adults and adolescents with COVID-19 who do not require further oxygen supply, and who are at risk of progressing to severe COVID-19.

A rolling review is often used by the EMA to speed up an assessment of a drug. The CHMP will review data of sotrovimab as it becomes available, rather than waiting for a formal application, meaning an opinion can be reached sooner.

The decision to start the review is based on the interim analysis from the Phase III COMET-ICE trial, which evaluated sotrovimab as a monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation.

Results of the analysis, based on data from 583 randomised patients, demonstrated an 85% reduction in deaths, or hospitalisations over 24 hours, in those receiving sotrovimab as compared to those on a placebo.

A separate review of sotrovimab is also underway to provide recommendations for countries in the EU who may decide on the use of the medicine for COVID-19 prior to marketing authorisation.

An Emergency Use Authorization (EUA) application for sotrovimab has already been submitted to the FDA in the US, while it is also under review by other global regulators, including Health Canada under the expedited Interim Order application pathway for COVID-19 drugs.

Sotrovimab is a COVID-19 monoclonal antibody. Pre-clinical data suggest it has the potential to both block viral entry into healthy cells and clear infected cells. The antibody binds to an epitope on SARS-CoV-2 (COVID-19) that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, and less likely to mutate over time.

Jack Goddard

Related Content


GSK’s RSV vaccine approved in EU for older adults

GSK has announced that the European Commission (EC) has authorised Arexvy, the company’s respiratory syncytial …

GSK receives FDA file acceptance for Jemperli plus chemotherapy for treating endometrial cancer

GSK has announced that the US Food and Drug Administration (FDA) has accepted the supplemental …

FDA approves first oral antiviral to treat adult patients with COVID-19

The US Food and Drug Administration (FDA) has announced that it has approved the oral …

Latest content