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Roche, Regeneron’s COVID-19 antibody cocktail cuts hospitalisation or death by 70%

Phase 3 trial is evaluating the therapy in high-risk non-hospitalised patients with COVID-19

Roche and Regeneron’s COVID-19 antibody cocktail has demonstrated positive results in a phase 3 trial assessing the investigational treatment in infected non-hospitalised patients.

The late-stage outcomes trial of casirivimab and imdevimab in high-risk, non-hospitalised COVID-19 patients hit its primary endpoint, demonstrating a 70% reduction in the risk of hospitalisation or death at the 1,200mg dose level administered intravenously (IV), and 71% at the 2,400mg IV dose level.

The antibody cocktail also met all key secondary endpoints in the REGN-COV 2067 trial, including the ability to reduce symptom duration by a median of four days.

A companion phase 2 trial – REGEN-COV 20145 – in low-risk symptomatic or asymptomatic non-hospitalised COVID-19 patients also showed significant and comparable viral load reduction across a number of doses ranging from 300 to 2,400mg.

The investigational COVID-19 treatment is also being studied in a phase 2/3 trial for the treatment of hospitalised patients, a phase 3 open-label trial of hospitalised patients in the UK and a phase 3 trial for the prevention of COVID-19 in those who share a household with infected individuals.

Roche and Regeneron will share detailed results from the phase 3 and companion phase 2 trials with regulatory authorities and also submit them for peer review ‘as soon as possible’.

Regeneron, the company that has commercialisation responsibilities for the antibody cocktail in the US, will share the new data with the US Food and Drug Administration (FDA).

Regeneron and Roche, the company that is responsible for sales outside the US, will continue to work with the European Medicines Agency (EMA) for regulatory approval of the investigational COVID-19 treatment.

At the beginning of February, the EMA launched a rolling review of the antibody cocktail for the treatment and prevention of COVID-19.

Following this, the EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a scientific opinion (under Article 5(3) of Regulation 726/2004) supporting the use of casirivimab and imdevimab as a treatment option for high-risk patients with confirmed COVID-19 who do not require oxygen supplementation.

This opinion can be considered by EU member states when making decisions on the use of the antibody cocktail at the national level before a formal authorisation is issued.

In the US, the FDA has granted Roche and Regeneron’s investigational treatment an emergency use authorisation (EUA) for the treatment of certain mild-to-moderate COVID-19 patients.

Article by
Lucy Parsons

23rd March 2021

From: Research



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