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03 Aug 2021 (Last Updated August 3rd, 2021 12:44) Celltrion filed new drug submission for the antibody treatment for rolling review in May. Share Article Regdanvimab lowered hospitalisation, oxygen need or death risk by 70% in Covid-19 patients versus placebo in Phase III trial. Credit: Dim Hou / Unsplash. Health Canada has granted priority review to Celltrion Healthcare’s experimental monoclonal antibody, regdanvimab (CT-P59), for the treatment of Covid-19. In May, Celltrion filed new drug submission (NDS) to the agency. The company noted that the screening phase was complete and the application has been accepted for review. The rolling submission process aids the company to submit safety and efficacy data and information when they become available.

Jovan antunovicEuropean medicines agencyHealth canadaCommittee for medicinal products human useCelltrion healthcareHealthcare canadaMedicinal productsHuman useஆரோக்கியம் கனடாகுழு க்கு மருத்துவ ப்ராடக்ட்ஸ் மனிதன் பயன்பாடுசுகாதாரம் கனடாமருத்துவ ப்ராடக்ட்ஸ்மனிதன் பயன்பாடு