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COVID-19: EU began to review GSK/Vir monoclonal antibody VIR-7831
EU began to review GSK/Vir monoclonal antibody VIR-7831: early treatment of high-risk COVID-19 patients!
The COVID-19 pneumonia epidemic is still spreading rapidly. As of 00:00 on April 16, 2021, more than 130 million (139.1 million) cases have been diagnosed globally, and more than 2.98 million deaths have been reported.
Recently, GlaxoSmithKline (GSK) and Vir Biotech jointly announced that the European Medicines Agency (EMA) has begun reviewing VIR-7831 (GSK4182136), which is a SARS-CoV-2 with dual effects. Monoclonal antibodies are used to treat adults and adolescents (12 years and older, weighing at least 40 kg) who do not require oxygen supplementation and are at high risk of developing severe COVID-19.
According to Article 5(3) of Regulation No. 726/2004, the Committee for Medicinal Products for Human Use (CHMP), an agency under the EMA, is conducting a review and will provide EU-wide scientific advice to regulatory agencies in EU member states. Regulatory agencies in these countries can make evidence-based decisions on the early use of drugs before any formal application for marketing authorization.
The review will include interim analysis data of the efficacy and safety data of the Phase 3 COMET-ICE (COVID-19 Monoclonal Antibody Efficacy Trial-Early Care Intention) trial. The trial evaluated the efficacy of VIR-7831 as a monotherapy for early treatment of COVID-19 adult patients at high risk of hospitalization.
An interim analysis based on data from 583 randomized patients showed that the trial reached the primary endpoint: compared with placebo, the hospitalization rate or mortality rate of patients treated with VIR-7831 was reduced by 85% (p=0.002). Therefore, the Independent Data Monitoring Committee (IDMC) recommended that the trial should be stopped due to evidence of significant efficacy. The CHMP review will also consider data on drug quality and safety.
This week, the Australian Therapeutic Goods Administration (TGA) under the Australian Ministry of Health granted VIR-7831 a provisional determination. VIR-7831 is the first anti-SARS-CoV-2 monoclonal antibody granted this qualification. The interim decision provides a formal and transparent mechanism to use preliminary clinical data to accelerate the registration of promising new drugs. Granting a provisional decision is a prerequisite for the provisional approval process, but it does not guarantee that the submission of registration will be accepted or that the provisional registration will be successful on ARTG.
At the end of March, GSK and Vir submitted an application to the U.S. Food and Drug Administration (FDA) requesting the granting of VIR-7831 Emergency Use Authorization (EUA) for the treatment of mild to moderate diseases that are at risk of progression to hospitalization or death Adults and adolescents with a degree of COVID-19 (12 years old and above, weighing at least 40 kg). The EUA submission is also based on the interim analysis data of the aforementioned Phase 3 COMET-ICE trial.
VIR-7831 (GSK4182136, image source: pharmaintelligence.informa.com)
GlaxoSmithKline plans to submit a biologics license application (BLA) to the US FDA and a complete marketing authorization application (MAA) to the European Medicines Agency (EMA), which will include data from the COMET-ICE trial. GlaxoSmithKline and Vir will continue to discuss with global regulatory agencies to provide VIR-7831 to COVID-19 patients as soon as possible.
VIR-7831 is a new type of coronavirus (SARS-CoV-2) monoclonal antibody with dual functions. Pre-clinical data shows that VIR-7831 also has the potential to block viruses from entering healthy cells and clear infected cells. VIR-7831 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 the development of drug resistance more difficult. VIR-7831 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.
Pre-clinical data also showed that VIR-7831 targets a highly conserved epitope of SARS-CoV-2 spike protein (Spike protein), which may make drug resistance more difficult. The new in vitro data of the Pseudotyped virus analysis published online in the preprint BioRxiv in March 2021 supports this hypothesis, confirming that VIR-7831 is effective against the current epidemic variants (including the UK, South Africa and Brazil variants). ) Stay active. According to other preclinical data published on BioRxiv, VIR-7831 also seems to maintain activity against the California variant.
(source:internet, reference only)