FDA grants emergency authorisation to Lilly’s COVID-19 antibody combination
pharmafile | February 11, 2021 | News story | | COVID-19, Eli Lilly
The FDA has granted emergency use authorisation for Eli Lilly’s antibodies bamlanivimab (LY-CoV555) 700mg and etesevimab (LY-CoV016) 1400mg, to be used together for the treatment of mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalisation.
Bamlanivimab and etesevimab should be administered together via a single intravenous infusion as soon as possible after a positive COVID-19 test, and within 10 days of symptom onset.
The FDA has also authorised infusion times for bamlanivimab alone and bamlanivimab and etesevimab together to be as short as 16 or 21 minutes, respectively – a significant reduction from the previously authorised time of 60 minutes. This decision has been made in response to feedback received from frontline nurses and doctors administering these infusions, and are aimed at reducing the burden on the healthcare system.
The approval is based on Phase III data from the BLAZE-1 trial, which demonstrated that bamlanivimab and etesevimab together reduced the risk of COVID-19 hospitalisations and death by 70%.
Bamlanivimab alone is authorised in numerous countries, while bamlanivimab and etesevimab together is currently authorised in the US and Italy. Lilly, in collaboration with Amgen, plans to manufacture up to 1 million doses of etesevimab for administration with bamlanivimab by mid-2021. There are 100,000 doses ready immediately, and an additional 150,000 doses will be available throughout the first quarter.
Dr Daniel Skovronsky, Lilly’s Chief Scientific Officer and President of Lilly Research Laboratories, said: “Bamlanivimab alone under emergency use authorisation has already provided many people with an early treatment option that could prevent hospitalisations and we are excited to now add an additional therapeutic option with a similar demonstrated clinical benefit.
“Additionally, with the risk of resistance emerging as various strains of the virus arise, bamlanivimab and etesevimab together could potentially allow efficacy against a broader range of naturally occurring SARS-CoV-2 variants as these new strains spread around the world.”
Darcy Jimenez
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