Celltrion’s Regdanvimab (CT-P59) Receives Korean MFDS Conditional Marketing Authorization for COVID-19

February 8, 2021 Auto Bot Celltrion, Clinical Trials, receives, Treatment 0

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  • The CMA is based on P-II/III study assessing CT-P59 vs PBO in patients with COVID-19. The CMA allows the emergency use of CT-P59 in patients aged ≥ 60yrs. with medical condition & mild symptoms of COVID-19, and adult with mod. symptoms of COVID-19
  • The study showed a reduction in risk of COVID-19 related hospitalization & oxygenation @28days; reduction in progression rates (54% for mild-to-mod. patients & 68% for mod. patients aged ≥50yrs.); time to clinical recovery (3.4 to 6.4days)
  • Celltrion is in discussion with the EMA for CMA and with the US FDA for EUA. The global P-III clinical trial is on track and is expected to enroll 1,172 patients with mild-to-mod. symptoms of COVID-19

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Businesswire

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