Regeneron’s COVID-19 antibody EUA reduced to lower dose by FDA

pharmafile | June 7, 2021 | News story | Sales and Marketing  

The FDA has updated the Emergency Use Authorisation (EUA) for Regeneron Pharmaceuticals’ COVID-19 antibody cocktail, REGEN-COV, halving the dose from 2,400mg to 1,200mg.

REGEN-COV is indicated for treating mild-to-moderate COVID-19 in adults as well as paediatric patients aged 12 years or above, who are at an increased risk for disease progression, including hospitalisation or death.

REGEN-CO is a combination of two monoclonal antibodies, casirivimab and imdevimab, and was designed utilising Regeneron’s VelocImmune and VelociSuite technologies to potentially hinder SARS-CoV-2 infectivity.

Previously, a 2,400mg (1,200mg casirivimab plus 1,200mg imdevimab) intravenous dose of REGEN-COV was authorised by the FDA.

The updated EUA says REGEN-COV should be given as IV doses and subcutaneous doses can be used when IV infusion is not practicable and could delay the treatment.

Regeneron Pharmaceuticals President and Chief Scientific Officer, George Yancopoulos, said: “Despite increased use of vaccines, thousands of patients are still becoming infected in the US every day, with many at high risk of serious complications from COVID-19.

“REGEN-COV has also demonstrated potency against the main variants of concern to date in vitro and is the only antibody therapy currently available across the US, including in states where variants first identified in Brazil and South Africa are circulating at a higher rate.”

This update is based on data from various clinical trials. Results from a Phase III trial demonstrated that REGEN-COV lowered the risk of hospitalisation or death by 70% high-risk non-hospitalised subjects.

Lilly Subbotin

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