· The CHMP positive opinion marks the first time a monoclonal antibody treatment for COVID-19 has received a recommendation for marketing authorisation from the EMA
· The recommendation is based on data from the global Phase III clinical trial investigating regdanvimab as a treatment for multiple variants of COVID-19, including the Delta variant
· Regdanvimab is the first authorised COVID-19 treatment approved from the Korean Ministry of Food and Drug Safety (MFDS); More than 21,366 people treated with regdanvimab in 127 hospitals in the Republic of Korea
INCHEON, Korea, Nov 15 (Bernama-BUSINESS WIRE) — Celltrion Group announced today that the European Medicine’s Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive scientific opinion recommending marketing authorisation for regdanvimab (CT-P59), a monoclonal antibody treatment for adults with COVID-19 that do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19. The CHMP positive opinion is a scientific recommendation to the European Commission (EC), which authorises marketing approval in the European Union.
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