FDA Expands Emergency Use Authorization for Junshi/Lilly COVID-19 Antibody Cocktail to Include All Age Groups

Source: PharmaCube Info

On December 5, Junshi Biosciences announced that the FDA had expanded the Emergency Use Authorization (EUA) scope for the combination therapy of etesevimab (JS016) and bamlanivimab (LY-CoV555). The authorization now includes the treatment of mild to moderate COVID-19 and post-exposure prophylaxis in certain high-risk pediatric populations (from birth to under 12 years old). Currently, this combination therapy is the world’s first and only neutralizing antibody therapy granted EUA coverage for individuals under 12 years old, providing a treatment and prevention option for high-risk populations of all age groups against COVID-19.

In February 2021, the dual-antibody therapy received FDA Emergency Use Authorization (EUA) for the treatment of mild to moderate COVID-19 patients aged 12 and above who are at risk of progressing to severe COVID-19 and/or hospitalization. In September 2021, the dual-antibody therapy was granted FDA EUA for post-exposure prophylaxis in individuals aged 12 and above at high risk of infection to prevent Coronavirus infection, including those who are not fully vaccinated against COVID-19 or are expected to have an insufficient immune response despite full vaccination, as well as those exposed to Coronavirus-infected individuals or in high-exposure institutional settings such as nursing homes or prisons.

The expansion of the emergency use authorization this time is based on the safety and efficacy data of pediatric and infant patients from the BLAZE-1 study (NCT04427501). BLAZE-1 is a Phase II/III clinical trial designed to investigate the treatment of mild to moderate COVID-19 patients at risk of progressing to severe disease using a dual-antibody therapy. According to daily symptom records from the clinical trial, the median time for complete symptom resolution was 7 days for participants receiving etesevimab (1400mg) and bamlanivimab (700mg) dual-antibody therapy, while it was 5 days for participants dosed based on body weight. No pediatric participants died or were hospitalized due to COVID-19.

Notably, studies on both pseudovirus and live virus have shown that the dual-antibody therapy maintained neutralizing activity against the Delta variant, which is currently the predominant variant of global concern. To date, more than 700,000 patients have received either the dual-antibody therapy or treatment with bamlanivimab, potentially preventing over 35,000 hospitalizations and at least 14,000 deaths during the peak of the pandemic.