[Photo by Yonhap]
Celltrion Inc. has completed a large-scale global phase 3 trial of its investigational Covid-19 drug Rekirona (regdanvimab), pushing the antibody treatment one step closer to global launch, the Korean biopharma company said on Monday.
Celltrion started patient enrollment in January to evaluate the drug’s efficacy and safety in some 1,300 patients in 13 countries including the U.S., Spain and Romania.
As of Apr. 26, no new safety signals emerged and there was no case of treatment discontinuation due to side effects.
Celltrion aims to complete the analysis of phase 3 trial data by the end of June and submit the results to domestic and foreign health authorities for regulatory clearance.
In Korea, Celltrion received conditional approval of the drug from the Ministry of Food and Drug Safety in February for the treatment of Covid-19 patients aged 60 years or older and high-risk patients with underlying medical conditions whose symptoms are mild to moderate.
Celltrion expects more patients will receive treatment benefits if the drug’s efficacy and safety endpoints are met as per the protocol.
Celltrion already rolled out Rekirona products to cover 100,000 patients and is ready to boost production depending on global demand.
By Park Yoon-gyun and Minu Kim
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