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Antibody cocktail REGEN-COV Emergency Use Authorization (EUA) updated: low-dose 1200mg to treat COVID-19 patients!
Antibody cocktail REGEN-COV Emergency Use Authorization (EUA) updated. Recently, Regeneron announced that the U.S. Food and Drug Administration (FDA) has updated the emergency use authorization (EUA) for antibody cocktail therapy REGEN-COV (casirivimab and imdevimab), reducing the dose to 1200mg (600mg casirivimab and 600mg imdevimab). ), which is half of the originally approved dose.
As part of the updated EUA, REGEN-COV should be administered by intravenous (IV) infusion; when intravenous infusion is not feasible and delays treatment, subcutaneous injection (SC) is an alternative method.
REGEN-COV is authorized under the EUA to treat high-risk people who have recently been diagnosed with mild to moderate COVID-19, specifically: the new coronavirus (SARS-CoV-2) direct test result is positive and there is a high risk Children and adults who develop severe COVID-19 and/or hospitalization, age ≥12 years, and weight ≥40 kg. The latest fact sheet deleted the previously approved 2400 mg intravenous infusion REGEN-COV dose.
The latest FDA authorization is based on data from multiple trials, including the recently announced Phase 3 trial, which shows that REGEN-COV can reduce the risk of hospitalization or death in high-risk non-hospital patients by 70%, and the therapeutic effects of the 1200mg and 2400mg doses are consistent. of. SC administration is approved based on all scientific evidence, including clinical, viral load reduction, and pharmacokinetic data.
In addition, in vitro studies have shown that REGEN-COV retains its efficacy against the main variants popular in the United States, including the P.1 variant and the B.1.351 variant. Therefore, REGEN-COV can still be used in all 50 states in the United States. At present, in 8 of these states, the combined frequency of P.1 and B.1.351 variants exceeds 10% of newly diagnosed COVID-19, and the prevalence of these and other variants is still under close monitoring.
REGEN-COV is a cocktail therapy consisting of two kinds of antibodies, which are directed against two independent and non-overlapping sites in the SARS-CoV-2 spike protein receptor binding region. They have a synergistic effect and can reduce The risk of virus mutation and escape. Data from non-human primates show that REGEN-COV can prevent SARS-CoV-2 infection and treat infected animals by accelerating virus clearance.
REGEN-COV was developed to treat and prevent COVID-19 infection. In August 2020, Roche and Regeneron reached a strategic cooperation to develop, manufacture and distribute REGEN-COV to all parts of the world. The drug will provide a much-needed treatment option for those infected with COVID-19 symptoms, and has the potential to be Prevent infection in high-risk populations who have been exposed to the virus, thereby slowing the spread of the global pandemic.
Regeneron is expected to submit REGEN-COV’s complete biologics license application (BLA) later this summer for the treatment of non-hospitalized OVID-19 outpatients. In addition to outpatients, REGEN-COV is continuing to be evaluated in prevention and certain hospitalized COVID-19 patients. to evaluate.
In April of this year, Regeneron and Roche announced the positive results of a phase 3 study (REGN-COV 206), which evaluated REGEN-COV in household contacts of people infected with the novel coronavirus (SARS-COV-2) The effect of reducing the risk of COVID-19 infection. The results showed that in individuals who were not infected at the time of entry, subcutaneous injection of REGEN-COV reduced the risk of symptomatic infection by 81%.
In addition, individuals who received REGEN-COV treatment but still experienced symptomatic infections disappeared within 1 week on average, compared to 3 weeks for placebo. During the study, no new or serious safety signals were observed.
Regeneron has submitted the above data to regulatory agencies to expand the scope of EUA use for the prevention of COVID-19.
(source:internet, reference only)