EC approves Celltrion’s COVID-19 mAb Regkirona
The European Commission (EC) has authorised Celltrion’s COVID-19 monoclonal antibody (mAb) treatment Regkirona (regdanvimab, CT-P59), the company announced yesterday.
The marketing authorisation allows for the use of Regkirona for the treatment of adults with COVID-19 who do not require supplemental oxygen and who are at an increased risk of progression to severe disease.
This approval is based on Celltrion’s Phase III trial, which evaluated the safety and efficacy of Regkirona among COVID-19 patients. According to data from this trial, Regkirona significantly reduced the risk of COVID-19 related hospitalisation or death by 72% for patients at high-risk of progressing to severe COVID-19.
Read more: https://www.pharmatimes.com/news/ec_approves_celltrions_covid-19_mab_regkirona_1383595
The marketing authorisation allows for the use of Regkirona for the treatment of adults with COVID-19 who do not require supplemental oxygen and who are at an increased risk of progression to severe disease.
This approval is based on Celltrion’s Phase III trial, which evaluated the safety and efficacy of Regkirona among COVID-19 patients. According to data from this trial, Regkirona significantly reduced the risk of COVID-19 related hospitalisation or death by 72% for patients at high-risk of progressing to severe COVID-19.
Read more: https://www.pharmatimes.com/news/ec_approves_celltrions_covid-19_mab_regkirona_1383595
