Eli Lilly’s antibody COVID-19 therapy reduces virus levels and hospitalisations

pharmafile | October 8, 2020 | News story | Manufacturing and Production Eli Lilly, FDA 

Eli Lilly is seeking Emergency Use Authorization from the FDA after releasing interim data based on early trial results.

The results they released were based on a randomised, double-blind, placebo-controlled Phase 2 study evaluating the treatments LY-CoV555 as a monotherapy and in combination with LY-CoV016, which bind with COVID-19’s spike protein. The combination met the primary endpoint of reducing the viral load, with most patients, including those receiving placebo, demonstrating near complete viral clearance by day 11. The company is working towards publishing this data in peer-reviewed journals. 

Daniel Skovronsky, Lilly’s Chief Scientific Officer and President of Lilly Research Laboratories, said: “Our teams have worked tirelessly the last seven months to discover and develop these potential antibody treatments. We believe the data generated to date provide sufficient evidence that both monotherapy and combination therapy may be effective to treat COVID-19 in patients with a high risk for serious outcomes. Lilly is diligently working with regulators around the world to make these treatments available.” 

Based on this data, the company said it has submitted an Emergency Use Authorization for its single use antibody therapy and expected to submit one for its combination therapy in November. It plans to have one million doses of its monotherapy ready in late December. 

Prior to an approval, the only way for a patient to get access to these treatments would be to participate in the clinical trials.

Conor Kavanagh

Related Content

Regeneron and Sanofi’s sBLA for Dupixent accepted by FDA for priority review

Regeneron Pharmaceuticals and Sanofi have announced that the US Food and Drug Administration (FDA) has …

FDA approves Eli Lilly and Boehringer Ingelheim’s Jardiance for chronic kidney disease treatment

Eli Lilly and Boehringer Ingelheim have announced that the US Food and Drug Administration (FDA) …

FDA grants ODD to Nexcella’s NXC-201 as treatment for amyloid light chain amyloidosis

Nexcella has announced that the US Food and Drug Administration (FDA) has granted orphan drug …

Latest content