FDA clears Lilly's COVID-19 antibody duo bamlanivimab, etesevimab for emergency use

Eli Lilly said Tuesday that it received FDA emergency-use authorisation (EUA) for a neutralising antibody cocktail combining bamlanivimab with etesevimab to treat mild-to-moderate COVID-19 in patients 12 and older who are at high risk for progressing to severe disease and/or hospitalisation. According to the company, 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.

Bamlanivimab, also known as LY-CoV555, was already authorised for emergency use in the US since November to treat mild-to-moderate COVID-19 in high-risk patients. Late last month, Eli Lilly reported that administering it together with etesevimab, formerly LY-CoV016, reduced COVID-19-related hospitalisations and deaths by 70% in a Phase III trial of recently infected, high-risk patients.

Shorter infusion times

Meanwhile, Eli Lilly said the FDA also cleared shorter infusion times for bamlanivimab alone, and bamlanivimab together with etesevimab, down to as low as 16 or 21 minutes, respectively, marking "a significant reduction" from the hour-long infusion time authorised previously. According to the drugmaker, the decision was made in response to feedback from front-line medical staff administering the infusions.

Aside from the US, bamlanivimab alone is cleared in numerous other countries, while the combination of bamlanivimab plus etesevimab is currently also authorised in Italy. Eli Lilly said it plans to work with regulators to make the antibody therapies available around the world, adding it will continue supplying bamlanivimab alone while ramping up production of etesevimab. Through an ongoing partnership with Amgen, Eli Lilly estimates being able to manufacture 1 million doses of etesevimab for administration with bamlanivimab by mid-2021, with 100,000 doses ready immediately and another 150,000 doses to become available throughout the first quarter.

Potential efficacy against range of variants

Daniel Skovronsky, president of Lilly Research Laboratories, said the latest EUA provides an additional early treatment option for COVID-19 patients "with a similar demonstrated clinical benefit" to bamlanivimab alone. Moreover, he suggested that with the risk of resistance emerging as various SARS-CoV-2 strains arise, "bamlanivimab and etesevimab together could potentially allow efficacy against a broader range of naturally occurring…variants as these new strains spread around the world."

Eli Lilly recently expanded an ongoing Phase II trial of bamlanivimab to include testing it with VIR-7831, a dual-action antibody being co-developed by GlaxoSmithKline and Vir Biotechnology, for use in low-risk patients with mild-to-moderate COVID-19. For related analysis, see ViewPoints: Eli Lilly validates Vir's more meticulous nAb strategy.

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