Eli Lilly’s COVID-19 treatment combination 87% effective in Phase III trial
pharmafile | March 11, 2021 | News story | | COVID-19, Eli Lilly, covid-19 treatment
Eli Lilly has shown positive results in its Phase III combination drug trial, which reduced hospitalisations and deaths related to COVID-19.
The recommended doses of 700mg and 1400mg of bamlanivimab and etesevimab respectively have already been granted Emergency Use Authorization by the FDA in the US, and have been given a positive scientific opinion by the CHMP in Europe.
The Phase III BLAZE-1 trial gave 769 high-risk patients either the two Lilly drugs together or a placebo, and resulted in an 87% reduction in hospitalisation or death.
The results are consistent with previous studies, including the Phase III cohort in which 2800mg doses of both drugs resulted in a risk reduction of 70%, and the Phase II trial in which bamlanivimab alone reduced the risk of hospitalisations and emergency room visits by approximately 70%.
There have been no deaths in any of the participants who received both Lilly treatments in either of the Phase III trials so far. However, 14 deaths were recorded in patients who took the placebo drug.
Lilly is also continuing to rally global regulators to make bamlanivimab alone available worldwide. It is already authorised for emergency use in several countries including Canada, and is approved under emergency pathways allowing for the pandemic in the US and EU.
Dr Daniel Skovronsky PhD, Lilly’s Chief Scientific Officer and President of Lilly Research Laboratories, said: “These positive results reinforce our previous findings and support the authorised dose of bamlanivimab 700mg with etesevimab 1400mg.
“These compelling data – in addition to the recent EUA from FDA, the CHMP decision from EMA and the recommendation for the therapy in the National Institutes of Health’s COVID-19 Treatment Guidelines – give healthcare providers additional information regarding the use of bamlanivimab and etesevimab together as a potentially life-saving treatment to help those most at risk for severe complications of COVID-19.”
He continued: “The consistent results observed in multiple cohorts of this trial over several months, even as new strains of COVID-19 have emerged, indicate bamlanivimab with etesevimab maintains its effects against a range of variants, particularly those circulating in the US.”
Jack Goddard
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