EMA issues advice on casirivimab and imdevimab antibody cocktail for the treatment of mild-to-moderate COVID-19 - Seite 2

Roche and Regeneron are collaborating to develop, manufacture and distribute casirivimab and imdevimab, to people around the globe, with the aim of having more than two million doses available in 2021. Regeneron will be responsible for distributing the antibody cocktail in the US and Roche will be responsible for distribution outside the US, with the first Roche-manufactured doses already being distributed. Casirivimab and imdevimab could provide a much-needed treatment option for infected individuals already experiencing symptoms of COVID-19, and may be able to prevent infection in people exposed to the virus, and hopefully help slow the spread of the global pandemic. 

The investigational antibody cocktail of casirivimab and imdevimab continues to be evaluated in clinical trials in multiple settings for COVID-19: in non-hospitalised and certain hospitalised patients, including the open-label RECOVERY trial of hospitalised patients in the UK, and a trial for the prevention of COVID-19 in household contacts of infected individuals. As of February 2021, approximately 23,000 people have participated in casirivimab and imdevimab clinical trials. Lower doses of casirivimab and imdevimab are also being studied with the aim of increasing the number of patients who could potentially be treated if the cocktail is approved.

In these exceptional times, Roche stands together with society, governments, healthcare providers and all those working to overcome the pandemic.

About the CHMP’s review under Article 5(3) of Regulation 726/2004
The intent of the Article 5(3) referral procedure is for the CHMP to develop a harmonised scientific opinion at the EU level on the quality, safety and efficacy of a medicine based on the currently available data. The scientific opinions can then be considered by EU member states when making decisions on the use of medicines at a national level before a formal authorisation is issued.

The review under Article 5(3) of Regulation 726/2004 was requested by the EMA’s Executive Director following preliminary discussions with the COVID-19 EMA pandemic task force (COVID-ETF), which brings together experts from across the European medicines regulatory network to advise on the development, authorisation and safety monitoring of medicines and vaccines for COVID-19.

About casirivimab and imdevimab
Casirivimab and imdevimab is a cocktail of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and was designed by Regeneron scientists to block infectivity of SARS-CoV-2, the virus that causes COVID-19. They evaluated thousands of fully-human antibodies produced by the company's proprietary VelocImmune mice, which have been genetically modified to have a human immune system, as well as antibodies identified from humans who have recovered from COVID-19.