Swissmedic grants temporary authorisation to Xevudy® for COVID-19 patients

Corona medication Xevudy from GlaxoSmithKline (containing the active substance sotrovimab) granted temporary authorisation in Switzerland

14.01.2022

Swissmedic has granted temporary authorisation to the medicinal product Xevudy, the prescription of which was already permitted in Switzerland under COVID-19 Ordinance 3. Xevudy is an antibody that can be used for treatment of coronavirus disease.

Swissmedic has granted temporary authorisation for Xevudy, concentrate for solution for infusion. Xevudy is indicated for treatment of COVID-19 in adults and adolescents aged 12 years and over and with a body weight of at least 40 kg if oxygen therapy or hospitalisation is not required due to the disease and there is a high risk of developing a severe form of COVID-19.

Xevudy should be used according to the official recommendations and taking into account the local epidemiological data on the SARS-CoV-2 variants in circulation.

The medicinal product contains the antibody sotrovimab and is administered intravenously. Preparation and administration should be initiated and monitored by a qualified healthcare professional.

Swissmedic reviewed the application for authorisation from 11 May 2021 onwards in a rolling submission. This involves continual collection and submission to Swissmedic of the data required. Use of the antibody medication in Switzerland has been permitted since 25 August 2021 based on the exceptions in COVID-19 Ordinance 3.

Patient data specifically concerning efficacy against the Omicron variant were not submitted. However, the laboratory data (in vitro) indicate that Xevudy is effective against the Omicron variant.

Supplementary information

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