Swiss regulator approves Roche-Regeneron Covid-19 drug
The Swiss medicines agency, Swissmedic, has given the green light to the monoclonal antibody cocktail Ronapreve developed by Roche and Regeneron for use in the treatment and prevention of Covid-19.
Ronapreve, a combination of two monoclonal antibodies (casirivimab and imdevimab), is approved for patients 12 years and up when “oxygen therapy or hospitalisation is not required and there is a high risk of developing a severe form of Covid-19,” Swissmedic said in a statementExternal link.
Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses.
The treatment can also be taken prophylactically when the immune response to Covid-19 vaccination is not adequate. It is the first drug authorised by the Swiss regulator for the prevention of Covid-19 in cases where there is not a sufficient immune response after vaccination due to other diseases or treatments.
Ronapreve is given as a single infusion into a vein or by injection under the skin. The application for the authorisation of the drug, submitted on March 5, didn’t include data on the efficacy of the drug against the Omicron variant.
Since-April, Ronapreve could be administered under the exceptions allowed in the Covid-19 Ordinance 3; an ordinance published by the Federal Council in June 2020 to combat the pandemic. This includes a list of products that can be placed on the market before the authorisation procedure is concluded.
The antibody cocktail has been authorised in several other locations including in Japan and the European Union. It has a conditional approval in the UK and Australia and is available for emergency use in the United States.
The Federal Office of Public Health (FOPH) has been building up its Covid-19 treatment reserves. On Monday, the FOPH announced that it had signed two additional contracts for more doses of both Ronapreve (4,000 doses) and the monoclonal drug sotrovimab (2,000 doses) developed by GlaxoSmithKline and Vir Biotechnology. The antibody for the latter was discovered by Swiss company Humabs BioMed.
This is on top of the 3,000 doses of each drug the government ordered earlier this year. Contract amounts are confidential for both drugs, according to the FOPH.
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