Eli Lilly and Company (LLY) has submitted an initial request for emergency use authorization for LY-CoV555 monotherapy in higher-risk patients who have been recently diagnosed with mild-to-moderate COVID-19. The company targets to submit a subsequent request for emergency use authorization for combination therapy in November. Lilly expects having data to support a biologics license application submission for combination therapy in the second quarter 2021.
Eli Lilly said data from a new interim analysis of the BLAZE-1 clinical trial showed that combination therapy with two of the company’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 for the treatment of symptomatic COVID-19 in the outpatient setting. The combination therapy has been generally well tolerated with no drug-related serious adverse events.
Daniel Skovronsky, Lilly’s chief scientific officer, said: “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.”
Eli Lilly plans to begin a pragmatic, open-label study in the coming weeks, enrolling patients treated with either monotherapy or combination therapy, with a focus on collecting data regarding hospitalizations, deaths and safety.
Lilly expects the company could supply as many as one million doses of 700 mg LY-CoV555 monotherapy in fourth quarter 2020, with 100,000 available in October. With respect to the supply of combination therapy, Lilly said it will have 50,000 doses available in fourth quarter 2020. The supply of combination therapy will increase substantially beginning in first quarter 2021.
The company noted that, moving forward, LY-CoV555 and LY-CoV016 will be referred to as bamlanivimab and etesevimab, respectively.
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