EMA Review of VIR-7831 for COVID-19 Underway
EMA has started its review of monoclonal antibody VIR-7831 (also known as GSK4182136) as a treatment for patients with COVID-19.
According to an April 15, 2021 press release, the European Medicines Agency (EMA) has started its review of monoclonal antibody VIR-7831 (also known as GSK4182136) as a treatment for patients with COVID-19.
VIR-7831 is an investigational dual action SARS-CoV-2 monoclonal antibody that has been developed through collaborative work by GlaxoSmithKline and Vir Biotechnology. The treatment is currently undergoing clinical trials to assess its efficacy and safety in the treatment of adults and adolescents (aged 12 years and older and weighing at least 40 kg) with mild-to-moderate COVID-19, who are at high risk of progressing to more severe COVID-19.
EMA’s review will include data from an interim analysis of the Phase III study, COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial—Intent to Care Early). The preliminary results indicate that VIR-7831 reduced the risk of hospitalization in patients studied by 85% when compared with placebo.
A more comprehensive rolling review of available data is expected to start prior to a possible application for marketing authorization, although the initial review will provide European Union-wide recommendations. EMA has revealed that it will provide communication on the outcome of the current review once it has been concluded.
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
