AbCellera (NASDAQ: ABCL) has announced FDA expansion of the EUA for bamlanivimab (LY-CoV55) 700 mg given with etesevimab 1400 mg to include post-exposure prophylaxis in preventing asymptomatic COVID-19 and SARS-CoV-2.
Bamlanivimab and etesevimab receive approval in adolescent treatment
In February 2021, the neutralizing antibodies received FDA approval for treating early SARS-CoV-2 infection. Thus, they can now be used to treat high-risk individuals above 12 years who have yet to receive complete COVID-19 vaccination. Equally, the antibodies can be used on individuals expected not to mount sufficient immune response after vaccination or those that have been exposed to infected individuals.
CEO Carl Hansen said, “The expanded use authorization for bamlanivimab together with etesevimab provides a way to protect the significant number of people who, because of their situational exposure risk or medical condition, remain vulnerable to COVID-19. More than 535,000 patients have been treated with bamlanivimab alone or together with etesevimab, potentially keeping more than 25,000 patients out of the hospital and saving more than 10,000 lives. With this expanded authorization, these antibodies, which have been shown to be effective against the highly contagious Delta variant, can now be used to protect some of the most at-risk people exposed to the virus.”
BLAZE-2 Study supported EUA expansion
The EUA’s expansion was based on findings from the Phase 3 BLAZE-2 study, which demonstrated that bamlanivimab reduced the risk of developing COVID-19 in care homes by up to 80% in patients and up to 57% in residents and employees of long-term care institutions. The COVID-19 Prevention Network and the National Institute of Allergy and Infectious Diseases (NIAID) collaborated on the study’s Eli Lilly and Company (Lilly).
Authentic virus and pseudovirus studies show that bamlanivimab and etesevimab can retain neutralization activity against the Delta and Alpha strains. Therefore, on September 2, 2021, the FDA, alongside the Assistant Secretary for Preparedness and Response (ASPR) office, resumed the distribution and shipment of the two neutralizing antibodies given together.