The European Medicines Agency (EMA) has begun reviewing GlaxoSmithKline and Vir Biotechnology’s anti-SARS-CoV-2 antibody. EMA is assessing the candidate in COVID-19 patients who do not require oxygen supplementation and are at high risk of disease progression.
GSK and Vir are trying to bring the antibody, known as both VIR-7831 and GSK4182136, to market in the EU on the strength of evidence including interim data from the phase 3 COMET-ICE study. Last month, GSK and Vir stopped the trial early after the interim review linked the antibody to an 85% reduction in death and hospitalization in the 29 days after randomization.
The EMA’s Committee for Human Medicinal Products is reviewing the data under regulations that have facilitated early access to other COVID-19 interventions in the EU. The committee will provide an EU-wide recommendation that national authorities can use to inform decisions about whether to grant early access to the drug. GSK is preparing to submit a full marketing authorization application.
GSK and Vir disclosed news of the progress in the EU alongside an update on their effort to enter the Australian market. The Therapeutic Goods Administration (TGA) granted a provisional determination to VIR-7831 this week, making it the first anti-SARS-CoV-2 antibody to achieve that status. Granting provisional determination positions the TGA to temporarily allow the use of a product on the basis of preliminary clinical data.
The regulatory progress puts GSK and Vir on track to bring VIR-7831 to market in multiple parts of the world. Late last month, GSK and Vir filed for emergency use authorization from the FDA. Talks with global regulators to make VIR-7831 available to COVID-19 patients are “ongoing,” the partners said.
Questions about the level of demand for VIR-7831 and other anti-SARS-CoV-2 antibodies in high-risk, pre-hospitalization COVID-19 patients remain unanswered. In the hospital setting, supplies of other anti-SARS-CoV-2 antibodies went unused in the U.S. during the winter wave of COVID-19 cases.