UPDATED: The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the antibody cocktail to treat confirmed COVID-19 in patients who do not require supplemental oxygen and who are at a high-risk of progressing to severe COVID-19.
The CHMP’s review took place in parallel to the EMA’s rolling review of REGEN-COV. When this review is finalised, it will be used as the basis for an EU marketing authorisation for the treatment.
Regeneron will stop placebo enrolment into a phase 3 study of its COVID-19 antibody cocktail REGEN-COV after the Independent Data Monitoring Committee (IDMC) found the treatment has ‘clear efficacy’.
The phase 3 trial is assessing the investigational treatment, which combines casirivimab with imdevimab, in outpatients with COVID-19.
In this trial, the IDMC found clear clinical efficacy on reducing the rate of hospitalisation and death with both doses of REGEN-COV (1,200mg and 2,400mg) tested in the study compared to placebo.
Following this, the IDMC has recommended halting enrolment into the placebo group, which Regeneron said it will do ‘immediately’.
From now on, the study will continue to enrol patients into both the 1,200mg and 2,400mg REGEN-COV treatment groups.
In a statement, Regeneron said that it had not yet had any access to the unblinded data that prompted the IDMC’s recommendation, including the relative treatment benefit of either REGEN-COV doses tested.
It added that it will share detailed results from the study when they are available in March 2021.
In January, Regeneron announced that the antibody cocktail can be used as a passive vaccine to prevent COVID-19 in people who are at high risk of infection.
The first exploratory analysis of 400 evaluable high-risk participants in the phase 3 prevention trial found that passive vaccination with REGEN-COV resulted in 100% prevention of symptomatic COVID-19 infections.
On top of that, the cocktail led to approximately 50% lower overall rates of infection – with infections occurring with REGEN-COV therapy all being asymptomatic.
The infections observed in the placebo group also had more than 100-fold higher peak viral loads compared to REGEN-COV-treated patients.
Last November, the US Food and Drug Administration (FDA) granted REGEN-COV an emergency use authorisation (EUA) for the treatment of mild to moderate COVID-19 in adults and paediatric patients at least 12 years of age who weigh at least 40kg and are at high risk of progressing to severe COVID-19 and/or hospitalisation.
Under the EUA, the recommended dose for REGN-COV is 1,200mg of casirivimab and 1,200mg of imdevimab administered as a single intravenous infusion.