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news.GlaxoSmithKline and Vir Biotechnology have announced the European Medicines Agency (EMA) review of VIR-7831 (GSK4182136) for the early treatment of Covid-19.
Ahead of any formal Marketing Authorisation Application (MAA), the review will assist in EU-wide recommendations for countries that may take evidence-based decisions on the premature use of the medicine.Credit: Mohamed Hassan/Pixabay.
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GlaxoSmithKline and Vir Biotechnology have announced the European Medicines Agency (EMA) review of VIR-7831 (GSK4182136) for the early treatment of Covid-19.
VIR-7831 is an investigational dual-action SARS-CoV-2 monoclonal antibody, which will be used for the treatment of adults and adolescents (aged 12 years and above and weighing minimum 40 kg) suffering from Covid-19, who do not need additional oxygen but are at high risk of coming down with severe Covid-19.
The review is being conducted by the EMA Committee for Human Medicinal Products (CHMP) under Article 5(3) of Regulation 726/2004.
Ahead of any formal Marketing Authorisation Application (MAA), the review will assist in EU-wide recommendations for countries that may take evidence-based decisions on the premature use of the medicine.
The review will contain data from an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (Covid-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial.
COMET-ICE has evaluated VIR-7831 as monotherapy for the early treatment of Covid-19 in adults at high risk of disease progression and hospitalisation.
Results of the interim analysis demonstrated an 85% (p=0.002) reduction in hospitalisation or death in those being administered VIR-7831 when compared to placebo, the primary endpoint of the trial.
Due to evidence of profound efficacy, the Independent Data Monitoring Committee recommended stopping the trial for enrolment. The CHMP review will also take into account data on the medicine’s quality and safety.
The Australian Therapeutic Goods Administration (TGA) granted VIR-7831 a provisional determination this week.
VIR-7831 is the first anti-SARS-CoV-2 monoclonal antibody to be conferred this designation. It offers a transparent and formal mechanism for expediting the registration of promising new medicines with preliminary clinical data.
VIR-7831 has not been awarded a marketing authorisation anywhere in the world yet and is still an investigational compound.
An Emergency Use Authorization application for VIR-7831 has been presented to the US Food and Drug Administration.
GSK is planning to submit a full MAA to the EMA, supported by the data from the COMET-ICE trial.