COVID-19 medicine from Roche Pharma (Switzerland) AG can be used in Switzerland
Bern, 20.04.2021 - The active substances in "RegN-Cov 2", the COVID-19 medicinal product from Roche Pharma (Switzerland) AG, are now covered by the COVID-19 Ordinance 3 and may be placed on the market following the submission of an authorisation application to Swissmedic: On 16 April 2021, Swissmedic gave the go-ahead for the distribution of "RegN-Cov2", a concentrate for solution for infusion from Roche Pharma (Switzerland) AG. As a result, this medicinal product is available even before the authorisation decision has been taken.
During its session on 14 April 2021, the Federal Council approved the inclusion of the active substances contained in "RegN-Cov2", casirivimab and imdevimab, in Annex 5 of the COVID-19 Ordinance 3. This annex lists those active substances that may be used, subject to certain preconditions, in COVID patients even before they are authorised. Since the required authorisation application has been submitted to Swissmedic by Roche, the Ordinance allows the applicant to place the medicinal product on the market before its development is concluded and its quality, safety and efficacy have been reviewed by Swissmedic.
Swissmedic continuously reviews the submitted data, as well as data to be submitted in future, in the rolling authorisation procedure. Therefore, the official decision issued by Swissmedic merely establishes that the required data relating to the authorisation application have been submitted.
Exploiting the opportunities of new active substances
Annex 5 of COVID-19 Ordinance 3 lists those active substances that may be placed on the market before the authorisation procedure is concluded, provided Swissmedic has received an authorisation application. These now include casirivimab and imdevimab, the active substances contained in "RegN-Cov2", an artificial antibody cocktail that was developed to produce resistance to the SARS-Cov-2 coronavirus. In November 2020, the USA issued an emergency use authorisation for this combination for the treatment of mild to moderate COVID-19 in patients who are at risk of progression to a severe form of the disease. The medicinal product can also be used in the EU, without authorisation, following a positive recommendation of the Committee for Medicinal Products for Human Use (CHMP). Experience to date has shown that RegN-Cov2 can diminish the severity of the illness.
While the medicine may already be distributed, the ordinary process of authorisation by Swissmedic is continuing by way of the rolling procedure.
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