Celltrion’s COVID-19 antibody treatment ‘Rekkorna (ingredient regdanvirab)’ received conditional approval from the Swiss pharmaceutical regulatory authority on the 13th.
On November 13, last year, the European Commission (EC) received official approval for the first COVID-19 antibody treatment in Europe. As Switzerland is not a member of the EU, it has received a separate permit procedure.
According to SwissMedic, a Swiss pharmaceutical regulatory authority, on the 13th (local time), Lekkorna received temporary approval in Switzerland. It can be used for a limited period and is similar to the ‘conditional permission’ of some countries, including Korea.
With this Swiss approval, the injectable Lekkorina can be prescribed for treatment of adult patients with COVID-19 that do not require oxygen therapy or hospitalization.
The authorities explained, “We have been doing a rolling review of Rekkona, which was applied for approval in July of last year.
Celltrion is currently developing an ‘inhaled cocktail antibody therapy’ for the treatment of mutants of the Corona 19 virus, such as Omicron. It is a form of adding another antibody ‘CT-P63’, which has proven neutralizing ability to major mutations such as alpha, beta, gamma, and delta, and a formulation that changed Rekkona into an inhaled type.
On the other hand, Rekkorina has received official or conditional licenses from several countries, including Korea and Europe, Peru and Australia.