FDA Authorizes Lower 1,200 mg Dose of REGEN-COV Antibody Cocktail for Treatment of High-Risk COVID-19 Patients

June 5, 2021 /BioonBIOON/ -- Currently, the COVID-19 epidemic overseas is still spreading rapidly. According to Baidu's 《Real-time Novel Coronavirus Pneumonia EpidemicBig DataReport》, as of 00:00 on June 5, 2021, global cumulative confirmed casesOver 170 million (172.96 million) cases, with over 3.718 million deaths.

Recently, Regeneron announced that the U.S. Food and Drug Administration (FDA）has updated the Emergency Use Authorization (EUA) for the antibody cocktail therapy REGEN-COV (casirivimab and imdevimab),Reduce the dose to 1200 mg (600 mg casirivimab and 600 mg imdevimab), which is half of the initially approved dose.As part of the updated EUA, REGEN-COV should be administered via intravenous (IV) infusion; when IV infusion is not feasible and would result in a delay in treatment,Subcutaneous injection (SC) is an alternative method.

REGEN-COV is authorized under the EUA for the treatment of high-risk individuals recently diagnosed with mild to moderate COVID-19, specifically: pediatric and adult patients aged ≥12 years and weighing ≥40 kg who have tested positive for SARS-CoV-2 via a direct viral test and are at high risk for progression to severe COVID-19 and/or hospitalization. The updated Fact Sheet removes the previously approved 2400 mg intravenous infusion dose of REGEN-COV.

LatestFDAThe approval is based on data from multiple trials, including the recently reported Phase 3 trial, which demonstratedREGEN-COV reduces the risk of hospitalization or death by 70% in high-risk non-hospitalized patients, with consistent efficacy observed at the 1200 mg and 2400 mg doses.. SC administration was approved based on all scientific evidence, including clinical, viral load reduction, and pharmacokinetic data.

Furthermore, in vitro studies have demonstrated that REGEN-COV retains its efficacy against major variants circulating in the United States, including the P.1 and B.1.351 variants. Therefore, REGEN-COV remains authorized for use in all 50 U.S. states. Currently, in 8 of these states, the combined frequency of the P.1 and B.1.351 variants has exceeded that of newDiagnosis10% of COVID-19 cases, the prevalence of these and other variants remains under close monitoring.

REGEN-COV (Image source: maroc-hebdo.press.ma)

REGEN-COV is an antibody cocktail comprising two antibodies that target two distinct, non-overlapping epitopes on the receptor-binding domain of the SARS-CoV-2 spike protein. Acting synergistically, they reduce the risk of viral escape due to mutations. Non-human primate data demonstrate that REGEN-COV can prevent SARS-CoV-2 infection and treat infected animals by accelerating viral clearance.

REGEN-COV was developed for the treatment and prevention of COVID-19 infection. In August 2020, Roche and Regeneron entered into a strategic collaboration to develop, manufacture, and distribute REGEN-COV globally. The drug will provide a much-needed treatment option for patients already exhibiting symptoms of COVID-19, and has the potential to prevent infection in high-risk individuals who have been exposed to the virus, thereby helping to slow the spread of the global pandemic.

Regeneron expects to submit a complete Biologics License Application (BLA) for REGEN-COV later this summer for the treatment of non-hospitalized outpatients with COVID-19. In addition to outpatients, REGEN-COV continues to be evaluated for prevention and in certain hospitalized patients with COVID-19. In April of this year, Regeneron and Roche announced positive results from a Phase 3 study (REGN-COV 206) evaluating the efficacy of REGEN-COV in reducing the risk of COVID-19 infection among household contacts of individuals infected with the novel coronavirus (SARS-CoV-2). Results showed that among individuals who were uninfected at trial entry, subcutaneous administration of REGEN-COV reduced the risk of symptomatic infection by 81%. Furthermore, individuals who received REGEN-COV but still developed symptomatic infections experienced symptom resolution in an average of 1 week, compared to 3 weeks for placebo. No new or serious safety signals were observed during the study.

Regeneron has submitted the above data to regulatory authorities to expand the Emergency Use Authorization (EUA) for the prevention of COVID-19. (Bioon.com)

Original Source:FDA Authorizes Lower 1,200 mg Intravenous and Subcutaneous Dose of REGEN-COV™ (casirivimab and imdevimab) Antibody Cocktail to Treat Patients with COVID-19