Eli Lilly’s Bamlanivimab Receives FDA Emergency Use Authorization

November 11, 20200

Eli Lilly’s investigational neutralizing antibody bamlanivimab (LY-CoV555) 700 mg was granted an Emergency Use Authorization (EUA) by the US FDA to treat mild-to-moderate COVID-19 in adult and pediatric patients. This includes patients at high risk for progressing to severe COVID-19 and/or hospitalization and adults of 65 years or older, or who have certain chronic medical conditions and not for patients hospitalized due to COVID-19 or require oxygen therapy due to COVID-19 infection.  

The approval comes almost ten days after data from bamlanivimab’s Phase- II study, BLAZE-1, was published in the New England Journal of Medicine. The placebo-controlled, double-blind, randomized Phase –II Study, BLAZE-1, indicated a reduced viral load and rate of symptoms and hospitalizations in patients treated with bamlanivimab. The study was conducted in an outpatient setting with 456 non-hospitalized participants, out of which 156 were administered with placebo and the rest with different doses of bamlanivimab. The adverse events observed were majorly mild to moderate in severity, similar in both placebo and neutralizing antibody. According to the study, only 3% of the high-risk patients administered with bamlanivimab were hospitalized compared to 10% of the participants treated with a placebo. Since the treatment is administered, intravenously some events of allergic hypersensitivity and infusion reactions were also reported. Phase- III Study for bamlanivimab is ongoing, and Eli Lilly will continue to evaluate new data on the safety and efficacy of bamlanivimab.  

Bamlanivimab is a neutralizing IgG1 monoclonal antibody and emerged from the collaboration between Lilly and AbCellera to create antibody therapies to prevent and treat COVID-19. Eli Lilly scientists developed this antibody less than three months after discovering AbCellera and scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. Bamlanivimab is directed explicitly against the spike protein of SARS-CoV-2 and blocks the viral attachment to prevent the virus entry into human cells.   

With EUA being granted to Bamlanivimab 700 mg, the government will procure 300,000 vials, complying with its initial USD 375 million agreement, which also provides it with an option of obtaining 650,000 additional vials through 2021. In September, Eli Lilly and Amgen forged a manufacturing collaboration to scale up production of Eli Lilly’s antibody therapies by leveraging Amgen’s deep technical expertise in developing antibodies and exploiting its ability to manufacture complex biologics to cater to the increasing global demand for antibody therapies. 

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