Swiss regulator gives green light to first drug to prevent Covid-19

The drug is currently only approved for use to prevent Covid-19 among people who don't receive enough protection from vaccines. Copyright 2020 The Associated Press. All Rights Reserved

Swissmedic has issued a temporary marketing authorisation for AstraZeneca’s drug Evusheld, making it the first Covid-19 prophylaxis drug approved by the Swiss medical regulator.

This authorisation means that the drug, which is administered as an injection, can now be reimbursed by the federal government or health insurance under certain conditions. Evusheld, which is an antibody combination of Tixagevimab and Cilgavimab, is intended for people 12 years and older who aren’t able to build up sufficient immune defenses against Covid-19 from vaccines.

The federal government has already signed contracts with AstraZeneca’s Swiss subsidiary to procure the Covid-19 drug starting with 5,000 doses, according to Keystone-SDA.

Evusheld is authorised for use for Covid-19 prevention in the United States (emergency use), Japan, the European Union and several other countries. 

In the UK, where AstraZeneca has its headquarters, officials recently saidExternal link they will not purchase the drug citing “insufficient data” on the duration of protection it provides against the dominant variant Omicron and its subvariants.

On Friday, the EU extended its recommendation for the drug so that it can also be used as a treatment. Swissmedic is still reviewing Evusheld for use as a treatment. However, Swiss Covid regulations allow for the drug to be used to treat Covid-19 patients under certain conditions as the company’s application is being reviewed.

Other treatments

On Friday, the World Health Organization rescinded recommendations for two Covid-19 antibody therapies, stating that new variants have rendered them obsolete.

The two therapies, sotrovimab and casirivimab-imdevimab, were designed to work by binding to the spike protein of SARS-CoV-2 to neutralise the virus’ ability to infect cells.

GSK and partner Vir Biotechnology’s sotrovimab was pulled off the US market by the Food and Drug Administration (FDA) in April.

In January, the FDA also revised its stance on Casirivimab-imdevimab, which is sold under the name REGEN-COV. It limited the use of the drug sold by Swiss firm Roche and US firm Regeneron to a smaller group of patients, citing that it is less effective against the Omicron variant.

Both of the above drugsExternal link are authorised for use in Switzerland.