The FDA said Thursday that it has granted an emergency-use authorisation (EUA) to Eli Lilly's bamlanivimab 700mg and etesevimab 1400mg, administered together, for use as post-exposure prophylaxis to prevent COVID-19 in certain high-risk individuals. Specifically, the expanded EUA is for people 12 years and older, vaccinated or not, who have been exposed to someone infected with SARS-CoV-2 or who are at high risk of exposure in an institutional setting. The agency noted that the treatment is not intended for use to prevent COVID-19 if a person has not been exposed to the virus.
The neutralising antibody cocktail was initially granted an EUA in February to treat mild-to-moderate COVID-19 in patients 12 and older at high risk for progressing to severe disease and/or hospitalisation. Its use was restricted late last month to 22 states, where the frequency of variants resistant to bamlanivimab plus etesevimab was 5% or less. However, officials reversed course recently and allowed distribution to resume across the country, saying that a rise in prevalence of Delta appeared to have lowered the frequency of variants expected to be resistant to bamlanivimab and etesevimab.
The expanded EUA is based on data from the Phase III BLAZE-2 trial, which enrolled residents and staff at nursing and assisted living facilities across the US. The study population included 966 people who tested negative for SARS-CoV-2 at baseline, and who were randomised to receive either bamlanivimab 4200mg or placebo. The FDA noted that even though BLAZE-2 evaluated bamlanivimab alone, "it is reasonable to expect that bamlanivimab and etesevimab together may be safe and effective for post-exposure prophylaxis," as the combination of the two would likely have an advantage over bamlanivimab alone against certain variants.
After eight weeks of follow-up, there were 114 cases of symptomatic COVID-19 among staff and residents, with bamlanivimab reducing the risk by up to 57% compared to placebo. Among nursing home residents specifically, there were 45 cases of symptomatic COVID-19, translating to a roughly 80% reduced risk for bamlanivimab-treated people in this cohort. In addition, for a post-hoc subgroup involving all residents as well as all high-risk staff, there were 75 cases of symptomatic COVID-19, which worked out to a 72% reduction in risk with bamlanivimab.
"Despite very significant improvements to public health resulting from COVID-19 vaccination, with the rise of the highly contagious Delta variant, the virus continues to have a devastating impact on the most vulnerable individuals," remarked Daniel Skovronsky, president of Lilly Research Laboratories. He added that the expanded EUA will "help prevent the spread of COVID-19 to some of the most at-risk individuals in the US."
Earlier this week, Eli Lilly said it reached an agreement to supply the US with 388,000 doses of etesevimab by year-end to complement doses of bamlanivimab previously purchased by the government. The company said the transaction is expected to generate approximately $330 million in revenue in the second half of 2021.
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