GlaxoSmithKline and Vir submit Covid-19 mAb for emergency authorization
As the US continues to monitor the impact of variants on authorized monoclonal antibodies (mAbs) and shake up which mAbs are distributed where, GlaxoSmithKline and Vir Biotechnology said Friday that they’re seeking an emergency use authorization for their own mAb.
The companies are submitting an application for their mAb, known as VIR-7831, as a treatment for adults and adolescents (12 years and older) with mild-to-moderate Covid-19 who are at risk for progression to hospitalization or death.
The submission is based on an interim analysis of efficacy and safety data from a Phase III trial of 583 patients, which demonstrated an 85% (p=0.002) reduction in hospitalization or death in those receiving VIR-7831 compared to placebo. The trial’s Independent Data Monitoring Committee recommended that the trial stop enrollment because of the early sign of efficacy.
The company also said the mAb may be protective against some of the circulating variants. New in vitro data published as a pre-print earlier this month showed the mAb maintains activity against current variants of concern originating in the UK, South Africa and Brazil. Additional preclinical data showed the mAb also appears to maintain activity against the California variant, the company said.
The news of the submission comes as the US government and Eli Lilly agreed to halt all distribution of the company’s Covid-19 monoclonal antibody bamlanivimab as of Wednesday due to the “sustained increase” of variants in the US.
“We recognize the U.S. government has made the decision to no longer allow direct ordering of bamlanivimab alone due to concerns about the prevalence of the California (B.1.427/B.1.429) and New York (B.1.526) variants of SARS-CoV-2. The U.S. government has enabled direct ordering of bamlanivimab and etesevimab together as well as etesevimab alone, to pair with bamlanivimab that sites of care have on hand,” Lilly said.
Lilly is also sponsoring an ongoing Phase 2 trial evaluating VIR-7831 in the outpatient setting in combination with bamlanivimab in low-risk adults with mild to moderate Covid-19.
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