Dopo l'opinione positiva del CHMP, EMA decide in 24 ore per l'autorizzazione all'immissione in commercio di Ronapreve (casirivimab/imdevimab) e Regkirona (regdanvimab) nel trattamento del COVID-19

Following the CHMP Opinion, the European Commission (EC) has already granted its Decision for Roche's Ronapreve (casirivimab/imdevimab) and Celltrion's Regkirona (regdanvimab) marketing authorization applications for the treatment of COVID-19 in a record time (24 h following CHMP Positive Opinion).

The products have the following full indications:

• Ronapreve

"Ronapreve is indicated for:
- Treatment of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.
- Prevention of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg.
See sections 4.2, 4.4 and 5.1."

As a reminder, outside of the EU, Ronapreve has been approved for use in Japan and conditionally in the United Kingdom and Australia, and is authorised for emergency or temporary pandemic use in additional territories, including the United States, India and Canada. 

• Regkirona

"Regdanvimab is indicated for the treatment of adults with coronavirus disease 2019 (COVID-19) who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19 (see section 5.1)."

As a reminder, Regkirona has Emergency use authorisations (EUAs) in place in Indonesia and Brazil, and is fully approved in the Republic of Korea. In the U.S., regdanvimab has not yet been approved by the Food and Drug Administration (FDA), but the company is in discussion with the FDA to submit applications for an Emergency Use Authorisation (EUA).

EC Decision Ronapreve; SmPC Ronapreve; EC Decision Regkirona; SmPC Regkirona