EMA starts rolling review of REGN-COV2 antibody combination (casirivimab/imdevimab)

EMA

1 February 2021 - EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on a medicine known as REGN-COV2 antibody combination (casirivimab/imdevimab), which is being co-developed by Regeneron Pharmaceuticals and Roche for the treatment and prevention of COVID-19.

The CHMP’s decision to start the rolling review is based on preliminary results from a study that indicate a beneficial effect of the medicine in reducing the amount of virus in the blood (viral load) in non-hospitalised patients with COVID-19. However, EMA has not yet evaluated the full study and it is too early to draw any conclusions regarding the benefit-risk balance of the medicine.

Read EMA press release

Michael Wonder

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Michael Wonder