HungaroTrial contributed to EU authorization of a new COVID-19 medication, Regkirona (CT-P59).
HungaroTrial Team is very proud to announce, that our company has played significant role in the clinical development program leading to successful European authorization of REGKIRONA (CT-P59), the anti COVID-19 human monoclonal antibody of Celltrion.
Just a day after the CHMP’s authorization recommendation, EMA released full authorization on 12th of November 2021, and now Regkirona (CT-P59) became an authorized product in EU.
HungaroTrial has managed the phase II. / III. clinical trial of CT-P59 in Serbia and North Macedonia, and enrolled 103 patients within 11 days, resulting in timely completion of the study.