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Lilly’s COVID-19 drug has EUA revoked in favour of combination therapy

pharmafile | April 19, 2021 | News story | Sales and Marketing COVID-19, Eli Lilly, FDA, covid-19 treatment, lilly, pharma, pharma news 

The FDA have revoked Emergency Use Authorization (EUA) of Eli Lilly’s bamlanivimab drug for the treatment of COVID-19, per the pharmaceutical company’s request.

The revocation is the final step in Lilly’s planned transition to provide only bamlanivimab and etesevimab together in the US, and comes as the combination treatment now becomes fully available.

All treatment sites in the US now have access to obtain doses of etesevimab for administration with bamlanivimab, which together neutralise more of the emerging COVID-19 variants in the US than bamlanivimab alone, including the California strain that currently accounts for 50% of cases in the state, and over 10% of cases in multiple other states.

A Phase III study last month showed that the two drugs combined reduced risk of hospitalisations and death in those with COVID-19 by 87%.

Bamlanivimab and etesevimab together are authorised for use under EUA for the treatment of mild to moderate COVID-19 in adults and children aged 12 and over, with positive results of a direct COVID-19 test, and who are at high risk for progressing to severe COVID-19 and/or hospitalisation.

Lilly is not requesting the withdrawal of its EUA for bamlanivimab alone in any other country at present, although it has reiterated that the drug, together with etesevimab, is preferred over bamlanivimab alone.

Dr Daniel Skovronsky PhD, Lilly’s Chief Scientific Officer and President of Lilly Research Laboratories, said: ”Lilly moved quickly to make bamlanivimab alone available as a potentially lifesaving medicine at a time when Americans were hardest hit by COVID-19.

“With the growing prevalence of variants in the US that bamlanivimab alone may not fully neutralise, and with sufficient supply of etesevimab, we believe now is the right time to complete our planned transition and focus on the administration of these two neutralising antibodies together.”

Jack Goddard

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