Express | Effective against a variety of new coronavirus mutants, EU CHMP supports the approval of neutralizing antibody therapy

▎Editor of WuXi AppTec's content team May 21, 2021, GlaxoSmithKline and Vir Biotechnology announced that the European Medicines Agency (EMA) Committee for Human Medicines (CHMP) has published the COVID-19 neutralizing antibody therapy sotrovimab Positive opinions support its approval for the treatment of adult and adolescent patients who do not require supplemental oxygen but are potentially at risk of developing severe COVID-19.

Sotrovimab is an investigational monoclonal antibody against the new coronavirus, which targets the conserved epitope of the spike protein.

Pre-clinical data show that it can not only block the virus from entering healthy cells, but also remove cells infected by the virus.

CHMP's positive opinion on sotrovimab is based on the review of data from multiple trials of the drug.

Including data analysis of the multi-center, randomized double-blind phase 3 clinical trial COMET-ICE, which evaluated the effectiveness and safety of sotrovimab as an early-stage COVID-19 monotherapy in high-risk hospitalized adults.

Based on the results of the interim data of 583 patients, sotrovimab reached the primary endpoint of the trial, that is, compared with the control group, the risk of hospitalization or death due to the progression of COVID-19 in the experimental group was reduced by 85% (p=0.
002).

In addition, CHMP also considers relevant data on drug quality and safety.

As the COVID-19 epidemic continues, the new coronavirus continues to produce new mutant strains.
CHMP has also reviewed the data of several in vitro studies.
In vitro test data of live viruses and pseudoviruses show that sotrovimab maintains a number of epidemic mutants that have received attention.
The activity includes the P.
1 variant originally found in Brazil, the B.
1.
427/B.
1.
429 variant found in California, the B.
1.
351 variant found in South Africa, and the B.
1.
1.
7 variant found in the United Kingdom.

Recent research published on the preprint website also proved that it maintains activity against the B.
1.
526 variant originally found in New York and the B.
1.
617 variant found in India.

Vir CEO Dr.
George Scangos said: “CHMP’s support is good news for patients, because it is now easier for EU member states to promote sotrovimab through temporary authorization.

According to our latest in vitro experimental data, sotrovimab is able to maintain The activity of all mutants of the new
coronavirus that is currently of concern.
We look forward to continuing to cooperate with regulatory agencies around the world to enable more patients in need to receive sotrovimab treatment and help end this pandemic.

"References: [1] EMA Issues Positive Scientific Opinion on GSK and Vir Biotechnology's Sotrovimab For the Early Treatment of COVID-19.
Retrieved May 21, 2021, from https://investors.
vir.
bio/news-releases/news-release-details/ema-issues -positive-scientific-opinion-gsk-and-vir Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendation.

If you need guidance on the treatment plan, please go to a regular hospital for treatment.