Eli Lilly submits emergency authorization request for its COVID-19 antibody drug

Eli Lilly said Oct. 7 that it has submitted a request for an emergency use authorization to the FDA for its COVID-19 antibody drug after clinical trials showed it may be effective to treat patients with high risk for serious outcomes. 

The drugmaker said data shows sufficient evidence that both their monotherapy and combination therapy antibody drugs may be effective to treat the virus. 

The combination therapy reduced the viral load, symptoms and number of hospitalizations in a phase 2 trial and saw no serious adverse effects. 

The monotherapy had some adverse effects, including infusion reactions, that Eli Lilly said were generally mild. Two patients experienced serious infusion reactions, but all patients recovered. 

Eli Lilly said it will publish the data in peer-reviewed journals as soon as possible. 

The drugmaker said it's already manufactured hundreds of thousands of doses of the drugs and has submitted an EUA request for its monotherapy for use in higher-risk patients recently diagnosed with mild to moderate COVID-19. It expects to submit an EUA request for the combination therapy in November. 

Read the full news release here.

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