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Roche: COVID-19 self-test approved in Germany, antibody cocktail approved for treatment in Europe

Christian Fernsby |
Roche today announced it has been granted special approval by the German Federal Institute for Drugs and Medical Devices (BfArM) to offer the SARS-CoV-2 Rapid Antigen Test using a simple nasal swab for patient self-testing in Germany.

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The test is a reliable rapid test for the qualitative detection of a specific SARS-CoV-2 antigen in nasal swab samples.

This rapid antigen test collects the sample from the front area of the nose instead of the nasopharynx, resulting in a simplified and more comfortable sampling procedure.

By following simple instructions, patients can perform the test at home with results ready after only 15 minutes. The test will be made available in pharmacies and requires no prescription.

Roche 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 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.

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.

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 U.S., with the first Roche-manufactured doses already being distributed.

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.

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