Eli Lilly Requests FDA Emergency Use Authorization for Its COVID-19 Monoclonal Antibody Treatment

Eli Lilly and Company (Indianapolis, Ind, USA) has submitted a request for emergency use authorization (EUA) for its COVID-19 monoclonal antibody treatment to the US Food and Drug Administration (FDA) after new data showed that its combination therapy met primary and secondary endpoints, and reduced viral load, symptoms and hospitalization.

The company has announced additional details on its SARS-CoV-2 neutralizing antibody programs, including interim data on combination therapy in recently diagnosed patients with mild-to-moderate COVID-19, and plans to make these therapies broadly available to patients. Data from a new interim analysis of the BLAZE-1 clinical trial showed that combination therapy with two of Lilly's SARS-CoV-2 neutralizing antibodies reduced viral load, symptoms and COVID-related hospitalization and ER visits. The randomized, double-blind, placebo-controlled Phase 2 study evaluated LY-CoV555 and LY-CoV016, which bind complementary regions of the SARS-CoV-2 spike protein, for the treatment of symptomatic COVID-19 in the outpatient setting. The combination therapy was generally well tolerated with no drug-related serious adverse events.

Based on the combination therapy data, along with the previously disclosed findings for LY-CoV555 monotherapy, Lilly has engaged global regulators, including the FDA regarding potential EUA. Lilly has now submitted an initial request for EUA for LY-CoV555 monotherapy in higher-risk patients who have been recently diagnosed with mild-to-moderate COVID-19. The company expects to submit a subsequent request for EUA for combination therapy in November, pending clinical trial enrollment, once additional safety data accumulate and sufficient supply is manufactured.

To be able to quickly provide treatment to patients around the world, Lilly invested in large-scale manufacturing of both antibodies at risk – even before data demonstrated their potential to become a meaningful therapeutic option for COVID-19. For monotherapy, Lilly is focused on the 700 mg dose of LY-CoV555 since similar clinical effects were seen across all dose levels tested in BLAZE-1. Lilly anticipates it could supply as many as one million doses of 700 mg LY-CoV555 monotherapy in Q4 2020, with 100,000 available in October. With respect to the supply of combination therapy, Lilly anticipates it will have 50,000 doses available in Q4 2020.

"Our teams have worked tirelessly the last seven months to discover and develop these potential antibody treatments," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories. "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."

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