Vir Biotechnology and GlaxoSmithKline have asked the FDA for emergency use authorization for their coronavirus-fighting dual-action antibody.
The duo is seeking an emergency OK for the treatment of adults and adolescents aged 12 and older with mild to moderate COVID-19 who are at risk of dying from or needing hospitalization.
The EUA submission is based on interim data from a phase 3 trial of the treatment, known as VIR-7831 or GSK4182136, that the companies stopped early. The drug reduced hospitalization or death by 85% compared to placebo, an interim analysis found.
At the time of the analysis, 583 people recently infected with COVID-19 and at high risk of hospitalization had received the antibody or placebo. In the 29 days after treatment, the antibody reduced the number of patients who died or needed hospitalization for more than 24 hours by 85% over placebo.
Eventually, the companies will use the study, COMET-ICE, as the basis for a biologics license application in the U.S. They are in talks with the European Medicines Agency and other regulators.
Vir and GSK’s drug is trailing other anti-SARS-CoV-2 antibodies from Eli Lilly and Regeneron, which garnered emergency nods late last year. However, supplies of those treatments were going unused, partly because they must be given by intravenous infusion in a narrow window of time after patients have started showing symptoms.
“Administrators have struggled to identify people who should get the antibody drugs because of delays in testing and a lack of coordination between testing sites and hospitals,” The New York Times reported in December.
Vir and GSK are working on that challenge by developing a formulation of the antibody that can be given by intramuscular injection. They plan to start a phase 3 study of this formulation in the second quarter. If effective, the intramuscular formulation could play a role in the longer-term response to COVID-19 given preclinical evidence that VIR-7831 binds to a piece of the spike protein that’s conserved across variants of the virus.