FDA authorises Lilly's COVID-19 antibody cocktail for prevention

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.

Based on BLAZE-2 results

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.

Additional supply deal with US

"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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