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GSK/Vir monoclonal antibody sotrovimab enters rolling review in EU
GSK/Vir monoclonal antibody sotrovimab enters rolling review in EU: early treatment of high-risk COVID-19 patients!
Recently, GlaxoSmithKline (GSK) and Vir Biotech jointly announced that the European Medicines Agency (EMA) has begun a rolling review of the data of sotrovimab (formerly known as VIR-7831, GSK4182136).
Sotrovimab is a dual-acting SARS-CoV-2 monoclonal antibody used for the treatment of adults and adolescents who do not require oxygen supplementation and are at high risk of developing severe COVID-19 (12 years and older, weighing at least 40 kg) .
EMA will evaluate all data on sotrovimab, including evidence from clinical trials, when such evidence is available. The rolling review will continue until there is sufficient evidence to support a formal marketing authorization application (MAA). EMA will assess whether the drug meets the usual efficacy, safety and quality standards. Although the overall review timeline is not yet predictable, the process should be faster than the regular evaluation due to the time gained during the rolling review.
The Committee on Medicinal Products for Human Use (CHMP), an agency under the EMA, is reviewing the data. The decision to initiate the rolling review was based on an interim analysis of the efficacy and safety data of the COMET-ICE (COVID-19 Monoclonal Antibody Efficacy Trial-Early Care Intention) Phase 3 trial. The trial evaluated the efficacy of sotrovimab as a monotherapy for early treatment of COVID-19 adult patients at high risk of hospitalization. The primary efficacy endpoint of the trial is the proportion of patients with COVID-19 progression. COVID-19 progression is defined as: requiring hospitalization for at least 24 hours or death within 29 days after randomization. An interim analysis based on data from 583 randomized patients showed that the trial reached its primary endpoint: compared with placebo, the hospitalization rate or mortality rate of patients treated with sotrovimab was reduced by 85% (p=0.002).
In addition, CHMP is also reviewing sotrovimab in accordance with Article 5(3) of Regulation No. 726/2004. It is expected to provide EU-wide scientific advice to the regulatory agencies of EU member states. The regulatory agencies of these countries may Before formal marketing authorization, an evidence-based decision is made on the early use of the drug.
At the end of March this year, GSK and Vir have submitted a sotrovimab emergency use authorization (EUA) application to the U.S. Food and Drug Administration (FDA): for the treatment of mild to moderate COVID-19 adults who are at risk of developing hospitalization or death And adolescents (12 years and older, weighing at least 40 kg). The EUA submission is also based on the interim analysis data of the aforementioned Phase 3 COMET-ICE trial. In addition, sotrovimab is also being reviewed by other global regulatory agencies including Health Canada.
sotrovimab (Image source: pharmaintelligence.informa.com)
Sotrovimab is a new type of coronavirus (SARS-CoV-2) monoclonal antibody with dual functions. Preclinical data shows that sotrovimab also has the potential to block the virus from entering healthy cells and eliminate infected cells. Sotrovimab can bind to an epitope shared by SARS-CoV-2 and SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make resistance generation 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 and have an extended half-life.
Preclinical data also showed that sotrovimab targets a highly conserved epitope of the SARS-CoV-2 spike protein (Spike protein), which may make the development of drug resistance more difficult. The new in vitro data from the Pseudotyped virus analysis published online in the preprint BioRxiv in March 2021 supports this hypothesis and confirms that sotrovimab maintains the current pandemic variants (including the UK, South Africa and Brazil variants) of interest active. Based on other preclinical data published on BioRxiv, sotrovimab also seems to maintain activity against the California variant.
(source:internet, reference only)