EMA issues advice on casirivimab and imdevimab antibody cocktail for the treatment of mild-to-moderate COVID-19
- CHMP has completed a review of available data for investigational antibody cocktail casirivimab and imdevimab (REGN-COV2) to be considered for the treatment of confirmed COVID-19
- CHMP scientific opinion supports national decision making within EU states on the use of the antibodies before a formal authorisation is granted during a public health emergency
Roche and Regeneron are collaborating on developing and manufacturing casirivimab and imdevimab; Roche will be responsible for distribution in Europe and other countries
outside the US
Basel, 26 February 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) confirmed today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a scientific opinion supporting the use of the investigational antibody cocktail, casirivimab and imdevimab, as a treatment option for patients with confirmed COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19.
The CHMP’s scientific opinion (under Article 5(3) of Regulation 726/2004) provides a harmonised, EU-level opinion on the efficacy, quality and safety of casirivimab and imdevimab. This review took place in parallel to the EMA’s ongoing rolling review process, which is used to speed up the formal marketing application assessment of a promising medicine during a public health emergency. Under Article 5(3), the CHMP assessed available data in patients with COVID-19, including data from the REGN-COV2 2067 trial, as well as supportive data from other settings.
“This advice by the CHMP regarding casirivimab and imdevimab is an important step towards addressing the COVID-19 pandemic in the EU,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “Initial data showed that patients treated with this investigational antibody cocktail saw a reduction in both viral loads and medically-attended visits. Together with our partner Regeneron, we will continue working with the EMA, governments and other health authorities across the globe to bring this antibody cocktail to as many patients as possible.”
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