Eli Lilly and Regeneron have applied to the Food and Drug Administration (FDA) for the permission to use emergency coronavirus drugs. Eli Lilly conducted clinical trials with the placebo group, as a result of which the drug has proven its antiviral action. Regeneron did not provide the research data, but the company’s drug was widely publicized by the US president.
Pharmaceutical companies Eli Lilly and Regeneron have requested the Food and Drug Administration (FDA) to authorize the emergency use of their experimental monoclonal antibody preparations for the treatment of patients infected with Covid-19.
Eli Lilly reports that the drug LY-CoV555 aimed at the treatment COVID-19 mild to moderate severity. It can also be used to prevent the deterioration of infected patients, belonging to risk groups, which include people over 65 and those who have obesity.
The drug was developed based on the blood sample of the patient who survived the coronavirus infection at the beginning of the outbreak, in collaboration with Eli Lilly and the Canadian company AbCellera Biologics. The pharmaceutical company promises to produce 100,000 doses of the drug in October and more than one million by the end of the year. In the next month, after receiving these studies, it is planned to submit a similar application for approval of the two-component antibody therapy called LY-CoV016, which was also created by the Chinese company Junshi Biosciences.
Last month, the company’s test results were published, according to which the drug monoclonal antibodies reduced the frequency of hospitalizations, compared with placebo in the study. 1.6% of participants who received the drug were hospitalized or visited the emergency department due to coronavirus infection, compared with 5.8% of placebo subjects.
Regeneron, in turn, filed the application on the same day when US President Donald Trump publicly praised the company’s drug, clinically proved its effectiveness, and called it “God’s blessing,” after the adoption of which “It immediately became easier.”
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